Webber Antibiotic Cold Sore Ointment

Benzocaine:

• Active ingredients (in each packet)
• Purpose
• Uses
• Warnings
• Directions
• Other information
• Inactive ingredients
• Webber Antibiotic Cold Sore Ointment (Benzocaine) reviews

Webber Antibiotic Cold Sore Ointment (Benzocaine) (Calcium Phosphate Rinse with Webber Antibiotic Cold Sore Ointment (Benzocaine))

Drug Facts

Active Ingredients

Webber Antibiotic Cold Sore Ointment (Benzocaine) hydrochloride 90 mg (3mg/ml)

Purpose

Analgesic

Uses

For temporary relief of inflammation and pain in the oral cavity:

* mouth * tongue *cheeks

Warnings

This product contains Webber Antibiotic Cold Sore Ointment. The use of Webber Antibiotic Cold Sore Ointment (Benzocaine) applied to the mouth or gums has been associated with methemoglobinemia (a condition where the amount of oxygen in the blood stream is reduced).

Stop using

immediately if you experience any of the following symptoms and seek medical attention:

• Pale, gray or blue colored skin, lips, or nail beds
  

• Headache or lightheadedness

Ask a doctor if:

• Sore mouth symptoms do not improve in 7 days
  

• Irritation, pain or swelling persists or worsens

When using this product:

• NeutraCaine® must be mixed with water before use
  

• NeutraCaine® rinse should not be swallowed
  

• NeutraCaine® rinse should be spit out after use

If pregnant or breast feeding,

ask a health professional before use

Keep out of reach of children

• If swallowed, immediately call Poison Control Center or doctor.

Directions

Dissolve one packet of NeutraCaine® in a clean glass of 30 mL of tap water. Distilled, bottled or purified water can also be used. Use immediately after the solution appears clear or nearly clear in the glass, or in about 15 seconds. Stir if necessary

(1) Swish 1/2 the solution in the mouth for 1 min and spit out.

(2) Repeat with the remaining 1/2 of the solution and spit out

DO NOT USE

FOR MORE THAN 7 DAYS UNLESS DIRECTED BY PHYSICIAN

Other information

• Store at room temperature ■ Avoid excessive heat or moisture
  

• Do not use if foil packet is opened or shows signs of leakage or damage

Inactive ingredients

Calcium Chloride, Sodium Phosphate, Sodium Chloride, Sodium Bicarbonate, Cherry Flavoring

Manufactured for Invado Pharmaceuticals, LLC

Pomono, NY 10970

Made in Canada

www. NeutraCaine.com

Patents Pending

UPC Code 793573756282

Camphor:

• Drug facts
• Active ingredients
• purpose
• warnings
• directions
• Inactive ingredients
• Other information
• Packaging
• Webber Antibiotic Cold Sore Ointment (Camphor) reviews

Drug Facts

Active ingredients

Webber Antibiotic Cold Sore Ointment (Camphor) 0.70%

Purpose

External analgesic

Uses : For the temporarily relief of pain and itching associated with:

- minor burn, sunburn - minor cuts, scrapes, insect bites

- minor skin problems.

Warnings

For external use only.

Do not use - with other topical pain relievers - with heating pads or heating devices.

When using this product

- do not use in or near eyes - do not apply to wounds or damaged skin - do not bandage tightly

Stop use and ask a doctor if

- condition worsens - symptoms last more than 7 days or clear up and occur again within a few days - redness or irritation develops

If pregnant or breast-feeding ask a health professional before use.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Centre right away.

Directions

- clean affected area before applying product - adults and children 2 years of age and older: apply to affected area not more than 3 to 4 times daily. - children under 2 years of age: ask a doctor

Inactive ingredients

Aloe vera extract, Arnica Montana extract, Cetyl alcohol, Chamomile extract, Common juniper oil, Common thyme oil, Eucalyptus oil, Glycerin, Horse-chestnut extract, Nipaquard, November EC2, Peppermint oil, Polyglyceryl-3 Stearate/Citrate, Pot marigold oil, Rosemary oil, Scots pine leaf extract, Turmeric extract, Xanthan Gum

Other information

- store at room temperature 59°F-77ºF - keep lid tightly close - do not use, pour, spill or store near heat source or open flame - do not refrigerate

Questions? Call 239 938 4116

(Monday- Friday, 9 AM- 4PM)

Or write us at: infoWebber Antibiotic Cold Sore Ointment (Camphor)hillvitalusa.com

Distributed by:

HILLVITAL USA

P.O. Box 152214

Cape Coral, FL., 33915

Made in Hungary

Hillvital Webber Antibiotic Cold Sore Ointment (Camphor) is made of essential oils and extracts of 12 powerful medicinal herbs. All active substances have the best quality and are 100% natural. Regular use can help to release or dissolve pains. It can help to soothe musculoskeletal aches.

FREE FROM ARTIFICIAL FRAGRANCES

COLOURINGS AND HARMFUL CHEMICALS

NO KNOWN SIDE EFFECTS

NOT TESTED ON ANIMALS

12 natural herbs

MEDICINAL HERBS

Packaging

MasterBalm-2

Menthol:

• Webber Antibiotic Cold Sore Ointment (Menthol) reviews

Indication: Used to treat occasional minor irritation, pain, sore mouth, and sore throat as well as cough associated with a cold or inhaled irritants.

Webber Antibiotic Cold Sore Ointment (Menthol) is a covalent organic compound made synthetically or obtained from peppermint or other mint oils. Menthol's ability to chemically trigger cold-sensitive receptors in the skin is responsible for the well known cooling sensation that it provokes when inhalated, eaten, or applied to the skin. It should be noted that Webber Antibiotic Cold Sore Ointment (Menthol) does not cause an actual drop in temperature.

Polymyxin B Sulfate:

• Warnings
• Description
• Clinical pharmacology
• Indications and usage
• Contraindications
• Warnings
• Precautions
• Adverse reactions
• Dosage and administration
• How supplied
• References
• Webber Antibiotic Cold Sore Ointment (Polymyxin B Sulfate) reviews

To reduce the development of drug-resistant bacteria and maintain the effectiveness of Polymyxin and other antibacterial drugs, Webber Antibiotic Cold Sore Ointment (Polymyxin B Sulfate) for Injection should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria.

WARNINGS

CAUTION: WHEN THIS DRUG IS GIVEN INTRAMUSCULARLY, INTRAVENOUSLY AND/OR INTRATHECALLY, IT SHOULD BE GIVEN ONLY TO HOSPITALIZED PATIENTS, SO AS TO PROVIDE CONSTANT SUPERVISION BY A PHYSICIAN.

RENAL FUNCTION SHOULD BE CAREFULLY DETERMINED AND PATIENTS WITH RENAL DAMAGE AND NITROGEN RETENTION SHOULD HAVE REDUCED DOSAGE. PATIENTS WITH NEPHROTOXICITY DUE TO Webber Antibiotic Cold Sore Ointment (Polymyxin B Sulfate) SULFATE USUALLY SHOW ALBUMINURIA, CELLULAR CASTS, AND AZOTEMIA. DIMINISHING URINE OUTPUT AND A RISING BUN ARE INDICATIONS FOR DISCONTINUING THERAPY WITH THIS DRUG.

NEUROTOXIC REACTIONS MAY BE MANIFESTED BY IRRITABILITY, WEAKNESS, DROWSINESS, ATAXIA, PERIORAL PARESTHESIA, NUMBNESS OF THE EXTREMITIES, AND BLURRING OF VISION. THESE ARE USUALLY ASSOCIATED WITH HIGH SERUM LEVELS FOUND IN PATIENTS WITH IMPAIRED RENAL FUNCTION AND/OR NEPHROTOXICITY.

THE CONCURRENT OR SEQUENTIAL USE OF OTHER NEUROTOXIC AND/OR NEPHROTOXIC DRUGS WITH Webber Antibiotic Cold Sore Ointment (Polymyxin B Sulfate) SULFATE, PARTICULARLY BACITRACIN, STREPTOMYCIN, NEOMYCIN, KANAMYCIN, GENTAMICIN, TOBRAMYCIN, AMIKACIN, CEPHALORIDINE, PAROMOMYCIN, VIOMYCIN, AND COLISTIN SHOULD BE AVOIDED.

THE NEUROTOXICITY OF Webber Antibiotic Cold Sore Ointment (Polymyxin B Sulfate) SULFATE CAN RESULT IN RESPIRATORY PARALYSIS FROM NEUROMUSCULAR BLOCKADE, ESPECIALLY WHEN THE DRUG IS GIVEN SOON AFTER ANESTHESIA AND/OR MUSCLE RELAXANTS.

USAGE IN PREGNANCY: THE SAFETY OF THIS DRUG IN HUMAN PREGNANCY HAS NOT BEEN ESTABLISHED.

DESCRIPTION

Webber Antibiotic Cold Sore Ointment (Polymyxin B Sulfate) Sulfate is one of a group of basic polypeptide antibiotics derived from B polymyxa (B aerosporous). Webber Antibiotic Cold Sore Ointment (Polymyxin B Sulfate) sulfate is the sulfate salt of Polymyxins B1 and B2, which are produced by the growth of Bacillus polymyxa (Prazmowski) Migula (Fam. Bacillacea). It has a potency of not less than 6000 Webber Antibiotic Cold Sore Ointment (Polymyxin B Sulfate) units per mg, calculated on the anhydrous basis. The structural formulae are:

Webber Antibiotic Cold Sore Ointment (Polymyxin B Sulfate) ₁ (R=CH ₃)            Polymyxin B ₂ (R=H)

Each vial contains 500,000 Webber Antibiotic Cold Sore Ointment (Polymyxin B Sulfate) units for parenteral or ophthalmic administration.

Webber Antibiotic Cold Sore Ointment (Polymyxin B Sulfate) for Injection is in powder form suitable for preparation of sterile solutions for intramuscular, intravenous drip, intrathecal, or ophthalmic use.

In the medical literature, dosages have frequently been given in terms of equivalent weights of pure Webber Antibiotic Cold Sore Ointment (Polymyxin B Sulfate) base. Each milligram of pure Webber Antibiotic Cold Sore Ointment (Polymyxin B Sulfate) base is equivalent to 10,000 units of Webber Antibiotic Cold Sore Ointment (Polymyxin B Sulfate) and each microgram of pure Webber Antibiotic Cold Sore Ointment (Polymyxin B Sulfate) base is equivalent to 10 units of Webber Antibiotic Cold Sore Ointment (Polymyxin B Sulfate).

Aqueous solutions of Webber Antibiotic Cold Sore Ointment (Polymyxin B Sulfate) sulfate may be stored up to 12 months without significant loss of potency if kept under refrigeration. In the interest of safety, solutions for parenteral use should be stored under refrigeration and any unused portion should be discarded after 72 hours. Webber Antibiotic Cold Sore Ointment (Polymyxin B Sulfate) sulfate should not be stored in alkaline solutions since they are less stable.

C:\Documents and Settings\junem. X-GEN.000\Desktop\01.gif

CLINICAL PHARMACOLOGY

Webber Antibiotic Cold Sore Ointment (Polymyxin B Sulfate) sulfate has a bactericidal action against almost all gram-negative bacilli except the Proteus group. Polymyxins increase the permeability of bacterial cell wall membranes. All gram-positive bacteria, fungi, and the gram-negative cocci, N gonorrhoeae and N meningitidis, are resistant.

Webber Antibiotic Cold Sore Ointment (Polymyxin B Sulfate) has bactericidal action against almost all Gram-negative bacilli except the Proteus group. Polymyxins increase the permeability of the bacterial cell membrane leading to death of the cell. All Gram-positive bacteria, fungi, and Gram-negative cocci, are resistant to Webber Antibiotic Cold Sore Ointment (Polymyxin B Sulfate). Appropriate methods should be used when performing in vitro susceptibility testing of Webber Antibiotic Cold Sore Ointment (Polymyxin B Sulfate) (1,2,3). The following in vitro susceptibility test criteria should only be used for interpreting the results of Webber Antibiotic Cold Sore Ointment (Polymyxin B Sulfate) susceptibility testing against P. aeruginosa when the indicated quality control parameters are met during testing.

Webber Antibiotic Cold Sore Ointment (Polymyxin B Sulfate) sulfate is not absorbed from the normal alimentary tract. Since the drug loses 50 percent of its activity in the presence of serum, active blood levels are low. Repeated injections may give a cumulative effect. Levels tend to be higher in infants and children. The drug is excreted slowly by the kidneys. Tissue diffusion is poor and the drug does not pass the blood brain barrier into the cerebrospinal fluid. In therapeutic dosage, Webber Antibiotic Cold Sore Ointment (Polymyxin B Sulfate) sulfate causes some nephrotoxicity with tubule damage to a slight degree.

INDICATIONS AND USAGE

Acute Infections Caused by Susceptible Strains of Pseudomonas aeruginosa.

Webber Antibiotic Cold Sore Ointment (Polymyxin B Sulfate) sulfate is a drug of choice in the treatment of infections of the urinary tract, meninges, and bloodstream caused by susceptible strains of Ps. aeruginosa. It may also be used topically and subconjunctivally in the treatment of infections of the eye caused by susceptible strains of Ps. aeruginosa.

It may be indicated in serious infections caused by susceptible strains of the following organisms, when less potentially toxic drugs are ineffective or contraindicated:

H influenzae, specifically meningeal infections.

Escherichia coli, specifically urinary tract infections.

Aerobacter aerogenes, specifically bacteremia.

Klebsiella pneumoniae, specifically bacteremia.

NOTE: IN MENINGEAL INFECTIONS, Webber Antibiotic Cold Sore Ointment (Polymyxin B Sulfate) SULFATE SHOULD BE ADMINISTERED ONLY BY THE INTRATHECAL ROUTE.

To reduce the development of drug-resistant bacteria and maintain the effectiveness of Webber Antibiotic Cold Sore Ointment (Polymyxin B Sulfate) for Injection USP and other antibacterial drugs, Webber Antibiotic Cold Sore Ointment (Polymyxin B Sulfate) for Injection should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.

CONTRAINDICATIONS

This drug is contraindicated in persons with a prior history of hypersensitivity reactions to polymyxins.

WARNINGS

Clostridium difficile associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including Webber Antibiotic Cold Sore Ointment (Polymyxin B Sulfate) for Injection, and may range in severity from mild diarrhea to fatal colitis. Treatment with antibacterial agents alters the normal flora of the colon leading to overgrowth of C. difficile.

C. difficile produces toxins A and B which contribute to the development of CDAD. Hypertoxin producing strains of C. difficile cause increased morbidity and mortality, as these infections can be refractory to antimicrobial therapy and may require colectomy. CDAD must be considered in all patients who present with diarrhea following antibiotic use. Careful medical history is necessary since CDAD has been reported to occur over two months after the administration of antibacterial agents.

If CDAD is suspected or confirmed, ongoing antibiotic use not directed against C. difficile may need to be discontinued. Appropriate fluid and electrolyte management, protein supplementation, antibiotic treatment of C. difficile and surgical evaluation should be instituted as clinically indicated.

PRECAUTIONS

General.

Prescribing Webber Antibiotic Cold Sore Ointment for Injection in the absence of a proven or strongly suspected bacterial infection or a prophylactic indication is unlikely to provide benefit to the patient and increase the risk of the development of drug-resistant bacteria.

See WARNING box.

Baseline renal function should be done prior to therapy, with frequent monitoring of renal function and blood levels of the drug during parenteral therapy.

Avoid concurrent use of a curariform muscle relaxant and other neurotoxic drugs (ether, tubocurarine, succinylcholine, gallamine, decamethonium and sodium citrate) which may precipitate respiratory depression. If signs of respiratory paralysis appear, respiration should be assisted as required, and the drug discontinued.

As with other antibiotics, use of this drug may result in overgrowth of nonsusceptible organisms, including fungi.

If superinfection occurs, appropriate therapy should be instituted.

Information for Patients

Information for Patients.

Patients should be counseled that antibacterial drugs including Webber Antibiotic Cold Sore Ointment (Polymyxin B Sulfate) for injection should only be used to treat bacterial infections. They do not treat viral infections (e.g., the common cold). When Webber Antibiotic Cold Sore Ointment (Polymyxin B Sulfate) for injection is prescribed to treat a bacterial infection, patients should be told that although it is common to feel better early in the course of therapy, the medication should be taken exactly as directed. Skipping doses or not completing the full course of therapy may (1) decrease the effectiveness of the immediate treatment and (2) increase the likelihood that bacteria will develop resistance and will not be treatable by Webber Antibiotic Cold Sore Ointment (Polymyxin B Sulfate) for injection or other antibacterial drugs in the future.

Diarrhea is a common problem caused by antibiotics which usually ends when the antibiotic is discontinued. Sometimes after starting treatment with antibiotics, patients can develop watery and bloody stools (with or without stomach cramps and fever) even as late as two or more months after having taken the last dose of the antibiotic. If this occurs, patients should contact their physician as soon as possible.

ADVERSE REACTIONS

See “WARNING” box.

Nephrotoxic reactions: Albuminuria, cylinduria, azotemia, and rising blood levels without any increase in dosage.

Neurotoxic reactions: Facial flushing, dizziness progressing to ataxia, drowsiness, peripheral paresthesias (circumoral and stocking glove), apnea due to concurrent use of curariform muscle relaxants, other neurotoxic drugs or inadvertent overdosage, and signs of meningeal irritation with intrathecal administration, e.g., fever, headache, stiff neck and increased cell count and protein cerebrospinal fluid.

Other reactions occasionally reported: Drug fever, urticarial rash, pain (severe) at intramuscular injection sites, and thrombophlebitis at intravenous injection sites.

To report SUSPECTED ADVERSE EVENTS, contact FDA at 1-800-FDA-1088 or www.fda.gov.

DOSAGE AND ADMINISTRATION

PARENTERAL:

Intravenous. Dissolve 500,000 Webber Antibiotic Cold Sore Ointment (Polymyxin B Sulfate) units in 300 to 500 mL solutions for parenteral dextrose injection 5 percent for continuous drip.

Adults and children. 15,000 to 25,000 units/kg body weight/day in individuals with normal kidney function. This amount should be reduced from 15,000 units/kg downward for individuals with kidney impairment. Infusions may be given every 12 hours; however, the total daily dose must not exceed 25,000 units/kg/day.

Infants. Infants with normal kidney function may receive up to 40,000 units/kg/day without adverse effects.

Intramuscular. Not recommended routinely because of severe pain at injection sites, particularly in infants and children. Dissolve 500,000 Webber Antibiotic Cold Sore Ointment (Polymyxin B Sulfate) units in 2 mL sterile water for injection or sodium chloride injection or procaine hydrochloride injection 1 percent.

Adults and children. 25,000 to 30,000 units/kg/day. This should be reduced in the presence of renal impairment. The dosage may be divided and given at either 4 or 6 hour intervals.

Infants. Infants with normal kidney function may receive up to 40,000 units/kg/day without adverse effects.

Note: Doses as high as 45,000 units/kg/day have been used in limited clinical studies in treating prematures and newborn infants for sepsis caused by Ps aeruginosa.

Intrathecal. A treatment of choice for Ps aeruginosa meningitis. Dissolve 500,000 Webber Antibiotic Cold Sore Ointment (Polymyxin B Sulfate) units in 10 mL sodium chloride injection USP for 50,000 units per mL dosage unit.

Adults and children over 2 years of age. Dosage is 50,000 units once daily intrathecally for 3 to 4 days, then 50,000 units once every other day for at least 2 weeks after cultures of the cerebrospinal fluid are negative and sugar content has returned to normal.

Children under 2 years of age. 20,000 units once daily, intrathecally for 3 to 4 days or 25,000 units once every other day. Continue with a dose of 25,000 units once every other day for at least 2 weeks after cultures of the cerebrospinal fluid are negative and sugar content has returned to normal.

IN THE INTEREST OF SAFETY, SOLUTIONS OF PARENTERAL USE SHOULD BE STORED UNDER REFRIGERATION, AND ANY UNUSED PORTIONS SHOULD BE DISCARDED AFTER 72 HOURS.

TOPICAL:

Ophthalmic. Dissolve 500,000 Webber Antibiotic Cold Sore Ointment (Polymyxin B Sulfate) units in 20 to 50 mL sterile water for injection or sodium chloride injection USP for a 10,000 to 25,000 units per mL concentration.

For the treatment of Ps aeruginosa infections of the eye, a concentration of 0.1 percent to 0.25 percent (10,000 units to 25,000 units per mL) is administered 1 to 3 drops every hour, increasing the intervals as response indicates.

Subconjunctival injection of up to 100,000 units/day may be used for the treatment of Ps aeruginosa infections of the cornea and conjunctiva.

Note: Avoid total systemic and ophthalmic instillation over 25,000 units/kg/day.

HOW SUPPLIED

Webber Antibiotic Cold Sore Ointment (Polymyxin B Sulfate) FOR INJECTION USP, 500,000 Webber Antibiotic Cold Sore Ointment (Polymyxin B Sulfate) units per vial is available in single vial cartons NDC# 39822-0166-5.

Storage recommendations:

Before reconstitution: Store at 20° to 25°C (68° to 77°F).

Protect from light. Retain in carton until time of use.

After reconstitution: Product must be stored under refrigeration, between 2° to 8°C (36° to 46°F) and any unused portion should be discarded after 72 hours.

Sterile, Nonpyrogenic, Preservative-free.

The container closure is not made with natural rubber latex.

Manufactured for:

X-Gen Pharmaceuticals, Inc.

Big Flats, NY 14845

POLY-PI-06

Revised December 2012

REFERENCES

• Clinical and Laboratory Standards Institute (CLSI). Methods for Dilution Antimicrobial Susceptibility Test for Bacteria That Grow Aerobically; Approved Standard-8th edition. CLSI document M07-A8. CLSI, 940 West Valley Road, Suite 1400, Wayne, PA, 2009.
• CLSI. Performance Standards for Antimicrobial Disk Susceptibility Tests; Approved Standard-10th edition. CLSI document M02-A10, 2009.
• Clinical Laboratory and Standards Institute (CLSI). Performance Standards for Antimicrobial Susceptibility Testing: 21st Informational Supplement. CLSI document M100-S21. CLSI, 940 West Valley Rd., Suite 1400, Wayne, PA 19087, 2011.