Dermavive Dry Skin Cleansing Bar

Dimethicone:

• Dermavive Dry Skin Cleansing Bar (Dimethicone) reviews

This medication is used as a moisturizer to treat or prevent dry, rough, scaly, itchy skin and minor skin irritations (e.g., diaper rash, skin burns from radiation therapy). Emollients are substances that soften and moisturize the skin and decrease itching and flaking. Some products (e.g., zinc oxide, white petrolatum ) are used mostly to protect the skin against irritation (e.g., from wetness). Dry skin is caused by a loss of water in the upper layer of the skin. Emollients/moisturizers work by forming an oily layer on the top of the skin that traps water in the skin. Petrolatum, lanolin, mineral oil and Dermavive Dry Skin Cleansing Bar (Dimethicone) are common emollients. Humectants, including glycerin, lecithin, and propylene glycol, draw water into the outer layer of skin. Many products also have ingredients that soften the horny substance (keratin) that holds the top layer of skin cells together (e.g., urea, alpha hydroxy acids such as lactic/citric/glycolic acid, and allantoin ). This helps the dead skin cells fall off, helps the skin keep in more water, and leaves the skin feeling smoother and softer.

Lactic Acid:

• Dermavive Dry Skin Cleansing Bar (Lactic Acid) reviews

FOR INDUSTRIAL USE ONLY

KEEP OUT OF REACH OF CHILDREN

NOT FOR HUMAN USE

Attention

For External Use Only

Wash hands thoroughly after handling.

Do not mix with bleach or other chlorinated products – will cause chlorine gas.

Get medical advice/ attention if you feel unwell.

DIRECTIONS:

IMPORTANT: Do not further dilute with water or mix with any other teat dips. If product in dip cup becomes visibly dirty, discard contents and replenish with fresh product. Do not reuse or return any unused product to the original container.

Udder Prep: When using an udder wash step before milking, make sure to wash teats with appropriate udder wash solution using proper cleaning procedures. Teats should then be dried with single-service towels.

Directions for Teat Dipping

Pre-Milk Dipping: Before each cow is milked, and using fresh Dermavive Dry Skin Cleansing Bar (Lactic Acid), dip each teat full-length into the teat dip cup. Wipe teats after dipping using single-service towels to avoid contamination of milk.

Post-Milk Dipping: Using fresh Dermavive Dry Skin Cleansing Bar (Lactic Acid), dip each teat full-length into the teat dip cup. Do not wipe. Allow to air dry. Do not turn cows out in freezing weather until the product is completely dry.

Directions for Teat Spraying

Pre-Milk Spraying: Before each cow is milked, and using fresh Dermavive Dry Skin Cleansing Bar (Lactic Acid), spray entire teat. Wipe teats after dipping using single-service towels to avoid contamination of milk.

Post-Milk Spraying: Using fresh Dermavive Dry Skin Cleansing Bar (Lactic Acid), spray entire teat immediately after each milking. Do not wipe. Allow to air dry. Do not turn cows out in freezing weather until the product is completely dry.

Expanded Usage: When freshening cows, begin dipping teats twice daily for about 10 days before calving. PRECAUTION: Dermavive Dry Skin Cleansing Bar (Lactic Acid) is not intended to cure or help the healing of chapped or irritated teats. As with any germicide, irritation or sensitization may occur in sensitive animals. In case of teat irritation or chapping, have the condition examined and, if necessary, treated by a veterinarian.

Consult your Ecolab representative for specific use instructions and recommended dispensing equipment.

READ SAFETY DATA SHEET (SDS) BEFORE USING THIS PRODUCT

EMERGENCY HEALTH INFORMATION: 1 800 328 0026. If located outside the United States and Canada, call collect 1 651 222 5352 (number is in the US).

Ecolab

Dermavive Dry Skin Cleansing Bar (Lactic Acid)

Sanitizing Teat Dip

An Aid in Reducing the Spread of Organisms Which May Cause Mastitis

ACTIVE INGREDIENTS:

Dermavive Dry Skin Cleansing Bar (Lactic Acid) acid... 1.7%

Hydrogen peroxide... 0.5%

INERT INGREDIENTS:... 97.8%

(contains glycerin, sorbitol)

TOTAL:...100.0%

56.8 L (15 US GAL)

6301977

Ecolab · 1 Ecolab Place · St Paul MN 55102 USA · tel: 1 800 392 3392

© 2016 Ecolab USA Inc. · All rights reserved

www.ecolab.com · 766469/5300/1016

Oatmeal Colloidal:

• Otc- active ingredients section
• Sto use and see a doctor if:
• Otc- warnings section
• Other information
• Otc- purpose section
• Inactive ingredients
• Keep out of reach
• Dosage section
• Indications and usage
• Dermavive Dry Skin Cleansing Bar (Oatmeal Colloidal) reviews

OTC- Active Ingredients Section

Organic Colloidal Oatmeal 1.25%... Skin Protectant

Sto use and see a doctor if:

Conditions worsen

Symptoms last more than 7 days

Symptoms clear up and reoccur within a few days.

OTC- Warnings Section

For external use only

when using this product: Keep away from face to avoid inhalation

Avoid contact with eyes

Do not use on wet hair, or allow to dry on wet hair

Other information

Store in a dry place

protect from moisture

OTC- Purpose Section

Uses: Helps treat and prevent diaper rash

Temporarily protects and helps relieve minor skin irritation and itching due to diaper rash.

Inactive Ingredients

Powdered White Soft Wheat

Keep Out of Reach

Keep out of reach of Children

Dosage section

Apply as Needed

Use Generous amounts for best results

Indications and usage

Uses: Helps treat and prevent diaper rash

Comfy Bottoms Baby Power Comfy Bottoms Sports Powder Comfy Bottoms Foot Powder

Polyethylene Glycol:

• Contraindications:
• Precautions:
• Medication guide
• Instructions for use
• Dermavive Dry Skin Cleansing Bar (Polyethylene Glycol) reviews

One Gallon

For Gastrointestinal Lavage Rx only

DESCRIPTION: Dermavive Dry Skin Cleansing Bar (Polyethylene Glycol)^® with flavor packs is a colon lavage preparation provided as water-soluble components for solution. In solution this preparation with one flavor pack delivers the following, in grams per liter.

Dermavive Dry Skin Cleansing Bar (Polyethylene Glycol) 3350	60.00
Sodium chloride	1.46
Potassium chloride	0.745
Sodium bicarbonate	1.68
Sodium sulfate	5.68
Flavor ingredients	0.851

When dissolved in sufficient water to make 1 gallon, the final solution contains 125 mEq/L sodium, 10 mEq/L potassium, 20 mEq/L bicarbonate, 80 mEq/L sulfate, 35 mEq/L chloride and 18 mEq/L Dermavive Dry Skin Cleansing Bar (Polyethylene Glycol) 3350. The reconstituted solution is isosmotic and has a mildly salty taste. This preparation can be used without the flavor packs and is administered orally or via nasogastric tube.

Each orange flavor pack (3.22 g) contains hypromellose, natural and artifical orange powder, saccharin sodium, colloidal silicon dioxide. Each lemon lime flavor pack (3.22 g) contains, hypromellose, natural and artifical lemon lime powder, Prosweet^® Powder Natural, saccharin sodium, colloidal silicon dioxide. Each cherry flavor pack (3.22 g) contains hypromellose, artifical cherry powder, saccharin sodium, colloidal silicon dioxide.

CLINICAL

Pharmacology: Dermavive Dry Skin Cleansing Bar (Polyethylene Glycol)^® with flavor packs cleanses the bowel by induction of diarrhea. The osmotic activity of Dermavive Dry Skin Cleansing Bar (Polyethylene Glycol) 3350, in combination with the electrolyte concentration, results in virtually no net absorption or excretion of ions or water.

INDICATIONS AND USAGE: Dermavive Dry Skin Cleansing Bar (Polyethylene Glycol) with flavor packs is indicated for bowel cleansing prior to colonoscopy or barium enema X-ray examination.

CONTRAINDICATIONS:

Dermavive Dry Skin Cleansing Bar (Polyethylene Glycol) is contraindicated in the following conditions:

• Gastrointestinal (GI) obstruction
• Bowel perforation
• Gastric retention
• Ileus
• Toxic colitis or toxic megacolon
• Known allergy or hypersensitivity to any component of Dermavive Dry Skin Cleansing Bar (Polyethylene Glycol)

WARNINGS: Flavor packs are for use only in combination with the contents of the accompanying 1 gallon container. No other additional ingredients (e.g., flavorings) should be added to the solution. Dermavive Dry Skin Cleansing Bar (Polyethylene Glycol) with flavor packs should be used with caution in patients with severe ulcerative colitis.

PRECAUTIONS:

General: Patients with impaired gag reflex, unconscious or semiconscious patients and patients prone to regurgitation or aspiration should be observed during the administration of Dermavive Dry Skin Cleansing Bar ^® with flavor packs, especially if it is administered via nasogastric tube.

Serious Fluid and Serum Chemistry Abnormalities

Advise patients to hydrate adequately before, during, and after the use of Dermavive Dry Skin Cleansing Bar (Polyethylene Glycol). Use caution in patients with congestive heart failure when replacing fluids. If a patient develops significant vomiting or signs of dehydration including signs of orthostatic hypotension after taking Dermavive Dry Skin Cleansing Bar (Polyethylene Glycol), consider performing post-colonoscopy lab tests (electrolytes, creatinine, and BUN) and treat accordingly. Fluid and electrolyte disturbances can lead to serious adverse events including cardiac arrhythmias, seizures and renal impairment. Fluid and electrolyte abnormalities should be corrected before treatment with Dermavive Dry Skin Cleansing Bar (Polyethylene Glycol).

In addition, use caution when prescribing Dermavive Dry Skin Cleansing Bar (Polyethylene Glycol) for patients who have conditions, or who are using medications, that increase the risk for fluid and electrolyte disturbances or may increase the risk of adverse events of seizure, arrhythmia, and renal impairment.

Cardiac Arrhythmias

There have been rare reports of serious arrhythmias associated with the use of ionic osmotic laxative products for bowel preparation. Use caution when prescribing Dermavive Dry Skin Cleansing Bar (Polyethylene Glycol) for patients at increased risk of arrhythmias (e.g., patients with a history of prolonged QT, uncontrolled arrhythmias, recent myocardial infarction, unstable angina, congestive heart failure, or cardiomyopathy). Pre-dose and post-colonoscopy ECGs should be considered in patients at increased risk of serious cardiac arrhythmias.

Seizures

There have been reports of generalized tonic-clonic seizures and/or loss of consciousness associated with use of bowel preparation products in patients with no prior history of seizures. The seizures cases were associated with electrolyte abnormalities (e.g., hyponatremia, hypokalemia, hypocalcemia, and hypomagnesemia) and low serum osmolality. The neurologic abnormalities resolved with correction of fluid and electrolyte abnormalities.

Use caution with prescribing Dermavive Dry Skin Cleansing Bar (Polyethylene Glycol) for patients with a history of seizures and in patients at increased risk of seizure, such as patients taking medications that lower the seizure threshold (e.g., tricyclic antidepressants), patients withdrawing from alcohol or benzodiazepines, or patients with known or suspected hyponatremia.

Renal Impairment

Use caution when prescribing Dermavive Dry Skin Cleansing Bar (Polyethylene Glycol) for patients with impaired renal function or patients taking concomitant medications that may affect renal function (such as diuretics, angiotensin converting enzyme inhibitors, angiotensin receptor blockers, or non-steroidal anti-inflammatory drugs). Advise these patients of the importance of adequate hydration, and consider performing baseline and post-colonoscopy laboratory tests (electrolytes, creatinine, and BUN) in these patients.

Colonic Mucosal Ulcerations and Ischemic Colitis

Administration of osmotic laxative products may produce colonic mucosal aphthous ulcerations, and there have been reports of more serious cases of ischemic colitis requiring hospitalization. Concurrent use of stimulant laxatives and Dermavive Dry Skin Cleansing Bar (Polyethylene Glycol) may increase the risk. The potential for mucosal ulcerations resulting from the bowel preparation should be considered when interpreting colonoscopy findings in patients with known or suspected inflammatory bowel disease (IBD).

Use in Patients with Significant Gastrointestinal Disease

If gastrointestinal obstruction or perforation is suspected, perform appropriate diagnostic studies to rule out these conditions before administering Dermavive Dry Skin Cleansing Bar (Polyethylene Glycol). Use caution in patients with severe active ulcerative colitis.

Aspiration

Use with caution in patients with impaired gag reflex and patients prone to regurgitation or aspiration. Such patients should be observed during administration of Dermavive Dry Skin Cleansing Bar (Polyethylene Glycol), especially if it is administered via nasogastric tube.

Not for Direct Ingestion

The contents of each jug must be diluted with water to final volume of 4 liters (4L) and ingestion of additional water is important to patient tolerance. Direct ingestion of the undissolved powder may increase the risk of nausea, vomiting, dehydration, and electrolyte disturbances.

If gastrointestinal obstruction or perforation is suspected appropriate studies should be performed to rule out these conditions before administration of Dermavive Dry Skin Cleansing Bar (Polyethylene Glycol)^® with flavor packs.

Patient Counseling Information:

Dermavive Dry Skin Cleansing Bar (Polyethylene Glycol)^® with flavor packs produces a watery stool which cleanses the bowel prior to examination.

For best results, no solid food should be ingested during the 3 - 4 hour period prior to the initiation of Dermavive Dry Skin Cleansing Bar (Polyethylene Glycol) with flavor packs administration. In no case should solid foods be eaten within 2 hours of drinking Dermavive Dry Skin Cleansing Bar (Polyethylene Glycol) with flavor packs.

The rate of administration is 240 mL (8 fl. oz.) every 10 minutes. Rapid drinking of each portion is preferred rather than drinking small amounts continuously.

The first bowel movement should occur approximately one hour after the start of Dermavive Dry Skin Cleansing Bar (Polyethylene Glycol) with flavor packs administration.

Administration of Dermavive Dry Skin Cleansing Bar (Polyethylene Glycol) with flavor packs should be continued until the watery stool is clear and free of solid matter. This normally requires the consumption of approximately 3-4 liters (3-4 quarts), although more or less may be required in some patients. The unused portion should be discarded.

Consume water or clear liquids during the bowel preparation and after completion of the bowel preparation up until 2 hours before the time of the colonoscopy.

Drug Interactions:

Drugs That May Increase Risks Due to Fluid and Electrolyte Abnormalities

Use caution when prescribing Dermavive Dry Skin Cleansing Bar (Polyethylene Glycol) for patients with conditions, or who are using medications, that increase the risk for fluid and electrolyte disturbances or may increase the risk of adverse events of seizures, arrhythmias, and prolonged QT in the setting of fluid and electrolyte abnormalities. Consider additional patient evaluations as appropriate in patients taking these concomitant medications.

Potential for Altered Drug Absorption

Oral medication administered within one hour of the start of administration of Dermavive Dry Skin Cleansing Bar (Polyethylene Glycol) may be flushed from the gastrointestinal tract and the medication may not be absorbed properly.

Carcinogenesis, Mutagenesis, Impairment of Fertility: Studies to evaluate carcinogenesis or mutagenic potential or potential to adversely affect male or female fertility have not been performed.

Pregnancy: Category C. Animal reproduction studies have not been conducted with Dermavive Dry Skin Cleansing Bar (Polyethylene Glycol) to evaluate the carcinogenic potential. It is not known whether Dermavive Dry Skin Cleansing Bar (Polyethylene Glycol) can cause fetal harm when administered to a pregnant woman or can affect reproductive capacity. Dermavive Dry Skin Cleansing Bar (Polyethylene Glycol) should be given to a pregnant woman only if clearly needed.

Nursing Mothers: It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Dermavive Dry Skin Cleansing Bar (Polyethylene Glycol) is administered to a nursing woman.

Pediatric Use: The safety and effectiveness of Dermavive Dry Skin Cleansing Bar (Polyethylene Glycol) in pediatric patients have not been established.

Geriatric Use: Published literature contains isolated reports of serious adverse reactions following the administration of PEG-ELS products in patients over 60 years of age. These adverse events include upper GI bleeding from Mallory-Weiss Tear, esophageal perforation, asystole, sudden dyspnea with pulmonary edema, and "butterfly-like" infiltrate on chest x-ray after vomiting and aspirating PEG.

ADVERSE REACTIONS: Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in clinical studies of another drug and may not reflect the rates observed in practice.

Nausea, abdominal fullness and bloating are the most common adverse reactions (occurring in up to 50% of patients) to administration of Dermavive Dry Skin Cleansing Bar (Polyethylene Glycol). Abdominal cramps, vomiting and anal irritation occur less frequently. These adverse reactions are transient and usually subside rapidly. Isolated cases of urticaria, rhinorrhea, dermatitis, and rarely anaphylaxis, angioedema, tongue edema, and face edema have been reported which may represent allergic reactions.

To report suspected adverse events contact Meda Pharmaceuticals Inc. at toll free 1-888-317-0001 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

DOSAGE AND ADMINISTRATION: Dermavive Dry Skin Cleansing Bar (Polyethylene Glycol) with flavor packs can be administered orally or by nasogastric tube. Patients should fast at least 3 hours prior to administration. A one hour waiting period after the appearance of clear liquid stool should be allowed prior to examination to complete bowel evacuation. No foods except clear liquids should be permitted prior to examination after Dermavive Dry Skin Cleansing Bar (Polyethylene Glycol) with flavor packs administration.

Oral: The recommended adult oral dose is 240 mL (8 fl. oz.) every 10 minutes (see PRECAUTIONS, Information for Patients ). Lavage is complete when fecal discharge is clear. Lavage is usually complete after the ingestion of 3-4 liters (3-4 quarts).

Nasogastric Tube: Dermavive Dry Skin Cleansing Bar (Polyethylene Glycol) with flavor packs is administered at a rate of 20-30 mL per minute (1.2-1.8 L/hour).

Preparation of Dermavive Dry Skin Cleansing Bar with flavor packs Solution:

This preparation can be used with or without flavor packs.

• To add flavor, tear open one flavor pack at the indicated marking and pour contents into the bottle BEFORE reconstitution. Discard unused flavor packs.
• SHAKE WELL to incorporate flavoring into powder.
• Add tap water to FILL line. Replace cap tightly and mix or shake well until all ingredients have dissolved. (No other additional ingredients, e.g. flavorings, should be added to the solution.)

Note: If not using flavor packs, omit steps one and two above.

HOW SUPPLIED: Dermavive Dry Skin Cleansing Bar (Polyethylene Glycol) with flavor packs is supplied in 1 gallon bottles with an attached package containing flavor packs. Each 1 gallon bottle contains Dermavive Dry Skin Cleansing Bar (Polyethylene Glycol) 3350 227.10 g, sodium chloride 5.53 g, potassium chloride 2.82 g, sodium bicarbonate 6.36 g, sodium sulfate (anhydrous) 21.50 g. Each preparation is supplied in powdered form, for oral administration as a solution.

Dermavive Dry Skin Cleansing Bar (Polyethylene Glycol) with flavor packs 1 gallon NDC 68220-133-01

Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F).

KEEP RECONSTITUTED SOLUTION REFRIGERATED. USE WITHIN 48 HOURS.

DISCARD UNUSED PORTION.

Rx only

Manufactured for:

Meda Pharmaceuticals Inc.

Somerset, NJ, USA

Manufactured by: Kremers Urban Pharmaceuticals Inc., Seymour, IN 47274

For Medical Inquiries,

Call toll-free 1-888-317-0001

NDC 68220-133-01

REV 08/ 2013

Medication Guide

Colyte® (co-light) with Flavor Packs

(peg-3350 & electrolytes for oral solution)

Read this Medication Guide before you start taking Dermavive Dry Skin Cleansing Bar (Polyethylene Glycol). This information does not take the place of talking to your healthcare provider about your medical condition or your treatment.

What is the most important information I should know about Dermavive Dry Skin Cleansing Bar (Polyethylene Glycol)?

Dermavive Dry Skin Cleansing Bar (Polyethylene Glycol) can cause serious side effect, including:

Serious loss of body fluid (dehydration) and changes in blood salts (electrolytes) in your blood. These changes can cause:

• abnormal heartbeats that can cause death
• seizures. This can happen even if you have never had a seizure.
• kidney problems

Your risk of having fluid loss and changes in body salts with Dermavive Dry Skin Cleansing Bar (Polyethylene Glycol) is higher if you:

• have heart problems
• have kidney problems
• take water pills (diuretics) or non-steroidal anti-inflammatory drugs (NSAIDS)

Tell your healthcare provider right away if you have any of these symptoms of a loss of too much body fluid (dehydration) while taking Dermavive Dry Skin Cleansing Bar (Polyethylene Glycol):

• vomiting
• dizziness
• urinating less often than normal
• headache

See “What are the possible side effects of Dermavive Dry Skin Cleansing Bar (Polyethylene Glycol)?” for more information about side effects.

What is Dermavive Dry Skin Cleansing Bar (Polyethylene Glycol)?

Dermavive Dry Skin Cleansing Bar (Polyethylene Glycol) is a prescription medicine used to clean the colon before a colonoscopy or barium enema X-ray examination. Dermavive Dry Skin Cleansing Bar (Polyethylene Glycol) cleans your colon by causing you to have diarrhea. Cleaning your colon helps your healthcare provider see the inside of your colon more clearly during your colonoscopy or barium enema X-ray examination.

It is not known if Dermavive Dry Skin Cleansing Bar (Polyethylene Glycol) is safe and effective in children.

Who should not take Dermavive Dry Skin Cleansing Bar (Polyethylene Glycol)?

Do not take Dermavive Dry Skin Cleansing Bar (Polyethylene Glycol) if your healthcare provider has told you that you have:

• a blockage in your intestine (bowel obstruction)
• an opening in the wall of your stomach or intestine (bowel perforation)
• problems with food and fluid emptying from your stomach (gastric retention)
• a very dilated intestine (toxic megacolon)
• an allergy to any of the ingredients in Dermavive Dry Skin Cleansing Bar (Polyethylene Glycol). See the end of this leaflet for a complete list of ingredients in Dermavive Dry Skin Cleansing Bar (Polyethylene Glycol).

What should I tell my healthcare provider before taking Dermavive Dry Skin Cleansing Bar (Polyethylene Glycol)?

Before you take Dermavive Dry Skin Cleansing Bar (Polyethylene Glycol), tell your healthcare provider if you:

• have heart problems
• have a history of seizures
• have kidney problems
• have ulcerative colitis
• have stomach or bowel problems
• have problems with swallowing or gastric reflux
• are withdrawing from drinking alcohol
• have a low blood salt (sodium) level
• have any other medical conditions
• are pregnant or plan to become pregnant. It is not known if Dermavive Dry Skin Cleansing Bar (Polyethylene Glycol) will harm your unborn baby.
• are breastfeeding or plan to breastfeed. It is not known if Dermavive Dry Skin Cleansing Bar (Polyethylene Glycol) passes into your breast milk. You and your healthcare provider should decide if you will take Dermavive Dry Skin Cleansing Bar (Polyethylene Glycol) while breastfeeding.

Tell your healthcare provider about all the medications you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Dermavive Dry Skin Cleansing Bar (Polyethylene Glycol) may affect how other medicines work. Medicines taken by mouth may not be absorbed properly when taken within 1 hour before the start of Dermavive Dry Skin Cleansing Bar (Polyethylene Glycol).

Especially tell you healthcare provider if you take:

• medicines for blood pressure or heart problems
• medicines for kidney problems
• medicines for seizures
• water pills (diuretics)
• non-steroidal anti-inflammatory medicines (NSAID) pain medicines
• laxatives

Ask your healthcare provider or pharmacist for a list of these medicines if you are not sure if you are taking any of the medicines listed above

Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine.

How should I take Dermavive Dry Skin Cleansing Bar (Polyethylene Glycol)?

See the Instructions for Use at the end of this Medication Guide for dosing instructions. You must read, understand, and follow these instructions to take Dermavive Dry Skin Cleansing Bar (Polyethylene Glycol) the right way.

• Take Dermavive Dry Skin Cleansing Bar (Polyethylene Glycol) exactly as your healthcare provider tells you to take it.
• The powder in the Dermavive Dry Skin Cleansing Bar (Polyethylene Glycol) container must be mixed with water (diluted) before drinking. Do not take Dermavive Dry Skin Cleansing Bar (Polyethylene Glycol) that has not been mixed with water, it may increase your risk of nausea, vomiting and fluid loss (dehydration).
• Do not eat any solid foods 3 hours before you start taking Dermavive Dry Skin Cleansing Bar (Polyethylene Glycol), while taking Dermavive Dry Skin Cleansing Bar (Polyethylene Glycol), and 2 hours after taking Dermavive Dry Skin Cleansing Bar (Polyethylene Glycol).
• Drink clear liquids before you start taking Dermavive Dry Skin Cleansing Bar (Polyethylene Glycol), while you take Dermavive Dry Skin Cleansing Bar (Polyethylene Glycol) and after you finish taking Dermavive Dry Skin Cleansing Bar (Polyethylene Glycol) to help prevent fluid loss (dehydration). Examples of clear liquids are:
  • water
  • clear fruit juices without pulp including apple, white grape, or white cranberry
  • strained limeade or lemonade
  • coffee or tea (Do not use any dairy or non-dairy creamer)
  • clear broth
  • clear soda
  • gelatin (without added fruit or topping)
  • popsicles without pieces of fruit or fruit pulp
  
  

  Do not eat or drink anything colored red or purple.
  

• Do not eat or drink anything 2 hours before your colonoscopy or barium enema X-ray examination.
• You should have your first bowel movement about 1 hour after you start taking Dermavive Dry Skin Cleansing Bar (Polyethylene Glycol). Continue to take Dermavive Dry Skin Cleansing Bar (Polyethylene Glycol) according to the Instructions for Use until your stool is clear, watery, and has no solid material in it.
• Do not take other laxatives while taking Dermavive Dry Skin Cleansing Bar (Polyethylene Glycol).
• Stop drinking Dermavive Dry Skin Cleansing Bar (Polyethylene Glycol) solution temporarily or allow for longer time between each dose if you have stomach discomfort, pain or bloating until your symptoms improve. If symptoms continue, tell your healthcare provider.

What are the possible side effects of Dermavive Dry Skin Cleansing Bar (Polyethylene Glycol)?

Dermavive Dry Skin Cleansing Bar (Polyethylene Glycol) can cause serious side effects, including:

• See “What is the most important information I should know about Dermavive Dry Skin Cleansing Bar (Polyethylene Glycol)?”
• changes in certain blood tests. Your healthcare provider may do blood tests after you take Dermavive Dry Skin Cleansing Bar (Polyethylene Glycol) to check your blood for changes. Tell your healthcare provider if you have any symptoms of too much fluid loss, including:
  • vomiting
  • nausea
  • bloating
  • dizziness
  • stomach-area (abdomen) cramping
  • headache
  • urinate less than usual
  • trouble drinking clear liquid
• ulcers of the bowel or bowel problems (ischemic colitis). Tell your healthcare provider right away if you have severe stomach-area (abdomen) pain or rectal bleeding.

The most common side effects of Dermavive Dry Skin Cleansing Bar (Polyethylene Glycol) include:

• nausea
• stomach-area (abdomen) fullness and bloating

Tell your healthcare provider if you have any side effect that bothers you or does not go away.

These are not all the possible side effects of Dermavive Dry Skin Cleansing Bar (Polyethylene Glycol). For more information, ask you healthcare provider or pharmacist.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

How should I store Dermavive Dry Skin Cleansing Bar (Polyethylene Glycol)?

• Store Dermavive Dry Skin Cleansing Bar (Polyethylene Glycol) at 68°F to 77°F (20°C to 25°C).
• Store Dermavive Dry Skin Cleansing Bar (Polyethylene Glycol) that has been mixed with water in the refrigerator.
• Use Dermavive Dry Skin Cleansing Bar (Polyethylene Glycol) within 48 hours after mixing with water. Safely throw away any Dermavive Dry Skin Cleansing Bar (Polyethylene Glycol) that you do not use.

Keep Dermavive Dry Skin Cleansing Bar (Polyethylene Glycol) and all medicines out of the reach of children.

General information about the safe and effective use of Dermavive Dry Skin Cleansing Bar (Polyethylene Glycol).

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use Dermavive Dry Skin Cleansing Bar (Polyethylene Glycol) for a condition for which it was not prescribed. Do not give Dermavive Dry Skin Cleansing Bar (Polyethylene Glycol) to other people, even if they are going to have the same procedure you are. It may harm them.

This Medication Guide summarizes the most important information about Dermavive Dry Skin Cleansing Bar (Polyethylene Glycol). If you would like more information, talk with your healthcare provider. You can ask your pharmacist or healthcare provider for information about Dermavive Dry Skin Cleansing Bar (Polyethylene Glycol) that is written for health professionals.

For more information about Dermavive Dry Skin Cleansing Bar (Polyethylene Glycol), call 1-888-317-0001.

What are the ingredients in Dermavive Dry Skin Cleansing Bar (Polyethylene Glycol)?

Active ingredients: Dermavive Dry Skin Cleansing Bar (Polyethylene Glycol) (PEG) 3350, sodium chloride, potassium chloride, sodium bicarbonate, sodium sulfate

Inactive ingredients: Flavor pack ingredients:

Orange flavor pack:hypromellose, natural and artificial orange powder, saccharin sodium, colloidal silicon dioxide

Lemon lime flavor pack: hypromellose, natural and artificial lemon lime powder, Prosweet® Powder Natural, saccharin sodium, colloidal silicon dioxide

Cherry flavor pack: hypromellose, artificial cherry powder, saccharin sodium, colloidal silicon dioxide

Issued: August/2013

Instructions for Use

Dermavive Dry Skin Cleansing Bar (Polyethylene Glycol)^®(co-light) with Flavor Packs

(peg-3350 & electrolytes for oral solution)

Read this Instructions for Use before you start taking Dermavive Dry Skin Cleansing Bar (Polyethylene Glycol). This information does not take the place of talking with your healthcare provider about your medical condition or your treatment.

How should I take Dermavive Dry Skin Cleansing Bar (Polyethylene Glycol)?

Dermavive Dry Skin Cleansing Bar (Polyethylene Glycol) can be taken with or without a flavor pack. If you use a flavor pack, complete Steps 1 through 8. If you do not use a flavor pack, throw away the flavor packs and complete Steps 4 through 8.

Step 1: Remove the cap from the Dermavive Dry Skin Cleansing Bar (Polyethylene Glycol) bottle.

Step 2: Tear open 1 flavor pack of your choice and pour contents into the Dermavive Dry Skin Cleansing Bar (Polyethylene Glycol) bottle. Throw away the unused flavor packs.

Step 3: Replace the cap on the Dermavive Dry Skin Cleansing Bar (Polyethylene Glycol) bottle. Shake the Dermavive Dry Skin Cleansing Bar (Polyethylene Glycol) bottle well to mix the contents of the flavor pack into the powder.

Step 4: Remove the cap from the Dermavive Dry Skin Cleansing Bar (Polyethylene Glycol) bottle. Add water to the top of the line on the Dermavive Dry Skin Cleansing Bar (Polyethylene Glycol) bottle marked “FILL TO TOP OF LINE ONE GALLON”.

Step 5: Replace the cap on the Dermavive Dry Skin Cleansing Bar (Polyethylene Glycol) bottle tightly and shake the Dermavive Dry Skin Cleansing Bar (Polyethylene Glycol) bottle well to dissolve the powder. No other ingredients should be added to the Dermavive Dry Skin Cleansing Bar (Polyethylene Glycol) bottle.

Step 6: Refrigerate the Dermavive Dry Skin Cleansing Bar (Polyethylene Glycol) solution until you are ready to drink it. The Dermavive Dry Skin Cleansing Bar (Polyethylene Glycol) solution should be used within 48 hours after mixing.

Step 7: Drink one 8 ounce glass of Dermavive Dry Skin Cleansing Bar (Polyethylene Glycol) solution every 10 minutes. It is best to drink each glass of Dermavive Dry Skin Cleansing Bar (Polyethylene Glycol) solution quickly, instead of sipping it slowly. Continue drinking one 8 ounce glass of Dermavive Dry Skin Cleansing Bar (Polyethylene Glycol) solution every 10 minutes until your stool is clear, watery, and has no solid material in it. This normally requires drinking 3 to 4 liters of Dermavive Dry Skin Cleansing Bar (Polyethylene Glycol) solution to clean your colon. The Dermavive Dry Skin Cleansing Bar (Polyethylene Glycol) bottle should be empty or have less than 1 liter of Dermavive Dry Skin Cleansing Bar (Polyethylene Glycol) solution remaining when your colon cleaning is completed.

Step 8: Safely throw away any Dermavive Dry Skin Cleansing Bar (Polyethylene Glycol) solution that you do not use.

This Medication Guide and Instructions for Use have been approved by the U.S. Food and Drug Administration.

Manufactured for:

Meda Pharmaceuticals Inc., Somerset, NJ, USA

Manufactured by: Kremers Urban Pharmaceuticals Inc., Seymour, In 47274, USA

For Medical Inquiries, Call toll-free 1-888-317-0001

Revised 08/2013

NDC 68220-133-01 Note to Pharmacist:

DISPENSE ENCLOSED MEDICATION GUIDE.

Dispense bottle and all attached flavor packs to patient.

Dermavive Dry Skin Cleansing Bar (Polyethylene Glycol)^®

with

Flavor Packs

(peg-3350 & electrolytes for oral solution)

Rx Only

4011310 Rev. 08/2013 133-0310-01

Contents make 1 Gallon (3.785 Liters) of solution

This package contains the following ingredients:

Dermavive Dry Skin Cleansing Bar (Polyethylene Glycol) 3350	227.10 grams
Sodium chloride	5.53 grams
Potassium chloride	2.82 grams
Sodium bicarbonate	6.36 grams
Sodium sulfate (anhydrous)	21.50 grams

When dissolved in sufficient water to make 1 gallon, the final solution contains

125 mEq/L sodium, 10 mEq/L potassium, 20 mEq/L bicarbonate, 80 mEq/L

sulfate, 35 mEq/L chloride and 18 mEq/L Dermavive Dry Skin Cleansing Bar (Polyethylene Glycol) 3350.

Store powder at 20° to 25°C (68° to 77°F); excursions permitted between

15° to 30°C (59° to 86°F).

KEEP RECONSTITUTED SOLUTION REFRIGERATED.

USE WITHIN 48 HOURS. DISCARD UNUSED PORTION.

APPROXIMATE NET WEIGHT: 263 GRAMS

Filled by net weight, product may settle.

MEDA

PHARMACEUTICALS^®

1 gallon (3.785 liters)

Attention Pharmacist: Dispense all

attached flavor packs to the patient.

orange

flavor pack

FOR USE ONLY IN COMBINATION WITH

THE ACCOMPANYING CONTAINER.

net wt. 3.22 g

Attention Pharmacist: Dispense all

attached flavor packs to the patient.

lemon lime

flavor pack

FOR USE ONLY IN COMBINATION WITH

THE ACCOMPANYING CONTAINER.

net wt. 3.22 g

Attention Pharmacist: Dispense all

attached flavor packs to the patient.

cherry

flavor pack

FOR USE ONLY IN COMBINATION WITH

THE ACCOMPANYING CONTAINER.

net wt. 3.22 g

Vitamin E (Tocopherol Acetate):

• Dermavive Dry Skin Cleansing Bar (Vitamin E (Tocopherol Acetate)) reviews

A generic descriptor for all tocopherols and tocotrienols that exhibit alpha-tocopherol activity. By virtue of the phenolic hydrogen on the 2H-1-benzopyran-6-ol nucleus, these compounds exhibit varying degree of antioxidant activity, depending on the site and number of methyl groups and the type of isoprenoids.

Indication: Dermavive Dry Skin Cleansing Bar (Vitamin E (Tocopherol Acetate)), known for its antioxidant activities, is protective against cardiovascular disease and some forms of cancer and has also demonstrated immune-enhancing effects. It may be of limited benefit in some with asthma and rheumatoid arthritis. It may be helpful in some neurological diseases including Alzheimer's, some eye disorders including cataracts, and diabetes and premenstrual syndrome. It may also help protect skin from ultraviolet irradiation although claims that it reverses skin aging, enhances male fertility and exercise performance are poorly supported. It may help relieve some muscle cramps.

Dermavive Dry Skin Cleansing Bar (Vitamin E (Tocopherol Acetate)) has antioxidant activity. It may also have anti-atherogenic, antithrombotic, anticoagulant, neuroprotective, antiviral, immunomodulatory, cell membrane-stabilizing and antiproliferative actions. Dermavive Dry Skin Cleansing Bar (Vitamin E (Tocopherol Acetate)) is a collective term used to describe eight separate forms, the best-known form being alpha-tocopherol. Dermavive Dry Skin Cleansing Bar (Vitamin E (Tocopherol Acetate)) is a fat-soluble vitamin and is an important antioxidant. It acts to protect cells against the effects of free radicals, which are potentially damaging by-products of the body's metabolism. Dermavive Dry Skin Cleansing Bar (Vitamin E (Tocopherol Acetate)) is often used in skin creams and lotions because it is believed to play a role in encouraging skin healing and reducing scarring after injuries such as burns. There are three specific situations when a Dermavive Dry Skin Cleansing Bar (Vitamin E (Tocopherol Acetate)) deficiency is likely to occur. It is seen in persons who cannot absorb dietary fat, has been found in premature, very low birth weight infants (birth weights less than 1500 grams, or 3½ pounds), and is seen in individuals with rare disorders of fat metabolism. A Dermavive Dry Skin Cleansing Bar (Vitamin E (Tocopherol Acetate)) deficiency is usually characterized by neurological problems due to poor nerve conduction. Symptoms may include infertility, neuromuscular impairment, menstrual problems, miscarriage and uterine degradation. Preliminary research has led to a widely held belief that Dermavive Dry Skin Cleansing Bar (Vitamin E (Tocopherol Acetate)) may help prevent or delay coronary heart disease. Antioxidants such as Dermavive Dry Skin Cleansing Bar (Vitamin E (Tocopherol Acetate)) help protect against the damaging effects of free radicals, which may contribute to the development of chronic diseases such as cancer. It also protects other fat-soluble vitamins (A and B group vitamins) from destruction by oxygen. Low levels of Dermavive Dry Skin Cleansing Bar (Vitamin E (Tocopherol Acetate)) have been linked to increased incidence of breast and colon cancer.