Arthrex

Ammonium Salicylate:

• Indications and usage
• Contraindications
• Warning
• Precautions
• Adverse reactions
• Overdosage
• Dosage and administration
• How supplied
• Arthrex (Ammonium Salicylate) reviews

INDICATIONS AND USAGE

Arthrex (Ammonium Salicylate) Lactate Lotion, 12% is indicated for the treatment of dry, scaly skin (xerosis) and ichthyosis vulgaris, and for the temporary relief of itching associated with these conditions.

CONTRAINDICATIONS

Arthrex (Ammonium Salicylate) Lactate Lotion, 12% is contraindicated in those patients with a history of hypersensitivity to any of the label ingredients.

WARNING

Sun exposure (natural or artificial sunlight) to areas of the skin treated with Arthrex (Ammonium Salicylate) Lactate Lotion, 12% should be minimized or avoided (see PRECAUTIONS). The use of Arthrex (Ammonium Salicylate) Lactate Lotion, 12% should be discontinued if any hypersensitivity is observed.

PRECAUTIONS

General -

For external use only. Stinging or burning may occur when applied to skin with fissures, erosions, or that is otherwise abraded. Caution is advised when used on the face because of the potential for irritation. The potential for post-inflammatory hypo- or hyperpigmentation has not been studied.

Information for Patients

Patients using Arthrex (Ammonium Salicylate) Lactate Lotion, 12% should receive the following information and instructions:

• This medication is to be used as directed by the physician, and should not be used for any disorder other than for which it was prescribed. It is for external use only. Avoid contact with eyes, lips, or mucous membranes.
• Patients should minimize or avoid use of this product on areas of the skin that may be exposed to natural or artificial sunlight, including the face. If sun exposure is unavoidable, clothing should be worn to protect the skin.
• This medication may cause transient stinging or burning when applied to skin with fissures, erosions, or abrasions (for example, after shaving the legs).
• If the skin condition worsens with treatment, the medication should be promptly discontinued.

Carcinogenesis, Mutagenesis, Impairment of Fertility -

The topical treatment of CD-1 mice with 12%, 21% or 30% Arthrex lactate formulations for two-years did not produce a significant increase in dermal or systemic tumors in the absence of increased exposure to ultraviolet radiation. The maximum systemic exposure of the mice in this study was 0.7 times the maximum possible systemic exposure in humans. However, a long-term photocarcinogenicity study in hairless albino mice suggested that topically applied 12% Arthrex (Ammonium Salicylate) lactate formulations enhanced the rate of ultraviolet light-induced skin tumor formation.

The mutagenic potential of Arthrex (Ammonium Salicylate) lactate formulations was evaluated in the Ames assay and in the mouse in vivo micronucleus assay, both of which were negative.

In dermal Segment I and III studies with Arthrex (Ammonium Salicylate) lactate formulations there were no effects observed in fertility or pre- or postnatal development parameters in rats at dose levels of 300 mg/kg/day (1800 mg/m²/day), approximately 0.4 times the human topical dose.

Pregnancy:

Teratogenic effects:

Pregnancy Category B -

Animal reproduction studies have been performed in rats and rabbits at doses up to 0.7 and 1.5 times the human dose, respectively and have revealed no evidence of impaired fertility or harm to the fetus due to Arthrex (Ammonium Salicylate) lactate formulations. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, Arthrex (Ammonium Salicylate) Lactate Lotion, 12% should be used during pregnancy only if clearly needed.

Nursing Mothers -

Although lactic acid is a normal constituent of blood and tissues, it is not known to what extent this drug affects normal lactic acid levels in human milk. Because many drugs are excreted in human milk, caution should be exercised when Arthrex (Ammonium Salicylate) lactate is administered to a nursing woman.

Pediatric Use -

Safety and effectiveness of Arthrex lactate have been demonstrated in infants and children. No unusual toxic effects were reported.

Geriatric Use -

Clinical studies of Arthrex (Ammonium Salicylate) lactate lotion, 12% did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between elderly and younger patients. In general, dose selection for an elderly patient should be cautious.

ADVERSE REACTIONS

The most frequent adverse experiences in patients with xerosis are transient stinging (1 in 30 patients), burning (1 in 30 patients), erythema (1 in 50 patients) and peeling (1 in 60 patients). Other adverse reactions which occur less frequently are irritation, eczema, petechiae, dryness, and hyperpigmentation. Due to the more severe initial skin conditions associated with ichthyosis, there was a higher incidence of transient stinging, burning and erythema (each occurring in 1 in 10 patients).

OVERDOSAGE

The oral administration of Arthrex (Ammonium Salicylate) lactate to rats and mice showed this drug to be practically non-toxic (LD₅₀>15 mL/kg).

DOSAGE AND ADMINISTRATION

Shake well. Apply to the affected areas and rub in thoroughly. Use twice daily or as directed by a physician.

HOW SUPPLIED

Arthrex Lactate Lotion, 12% is available as follows:

225 g bottle (NDC 45802-419-54)

400 g bottle (NDC 45802-419-26)

STORAGE

Store at 20-25°C (68-77°F).

Manufactured By Perrigo, Bronx, NY 10457

Distributed By Perrigo, Allegan, MI 49010

0K5A7 RC F6

Rev 01-17

Camphor:

• Drug facts
• Active ingredients
• purpose
• warnings
• directions
• Inactive ingredients
• Other information
• Packaging
• Arthrex (Camphor) reviews

Drug Facts

Active ingredients

Arthrex (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: infoArthrex (Camphor)hillvitalusa.com

Distributed by:

HILLVITAL USA

P.O. Box 152214

Cape Coral, FL., 33915

Made in Hungary

Hillvital Arthrex (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

Capsicum:

• Uses
• Warnings
• When using this product
• Stop use and ask a doctor if
• If pregnant or breastfeeding
• Directions
• Inactive ingredients
• Arthrex (Capsicum) reviews

Active Ingredients Purpose

Arthrex (Capsicum).025% Topical Analgesic

Uses

Uses Temporarily relieves minor pain of muscles and joints associated with:

• arthritis
• simple back ache
  

• strains
• bruises
  

Warnings

Warnings For external use only.

When using this product

When using this product

• use only as directed
• do not bandage
• do not use with a heating pad
• avoid contact with eyes and mucous membranes
• do not apply to wounds, damaged, broken or irritated skin
• a transient burning sensation may occur upon application but generally disappears in several days
• if severe burning sensation occurs, discontinue use immediately
• do not expose the area treated with product to heat or direct sunlight
  

Stop use and ask a doctor if

Stop use and ask a doctor

• condition worsens
• symptoms persist for more than 7 days or clear up and occur again within a few days
• redness is present
• irritation develops
  

If pregnant or breastfeeding

If pregnant or breastfeeding, ask a health professional before use. Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Directions

adults and children over 18 years:

• apply to affected area
• massage into painful area until thoroughly absorbed
• repeat as necessary, but no more than 3 to 4 times daily
• WASH HANDS WITH SOAP AND WATER AFTER APPLYING
• children 18 years or younger: ask a doctor
  

Keep out of the reach of children.

Keep out of the reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Directions

Adults and children 2 years of age and older:

• Apply to painful muscles and joint. Gently massage thoroughly into affected area.
• Repeat as necessary but not more than 4 times daily.
  

Purpose

Active Ingredients Purpose

Arthrex (Capsicum).025%... Topical Analgesic

Inactive Ingredients

Aqueous (Deionized Water) infusion of botanicalextracts of Passiflora Incarnata, Arnica Montana, Ruscus Acluteatus, HypericumPerforatum, Arctium Lappa, Anthemis Nobilis, *Aloe Barbadensis, Custom blend of*Helianthus annuus (Sunflower Oil),* Olea Europaea (Olive Oil), *SimmondsiaChinenesis (Jojoba Oil), *Linum Usitatissimum (Flax Seed Oil), BoswelliaSerrata, Methylsulfonylmethane, Glycerin,Ceteareth-20, Cetyl Alcohol, Stearyl Alcohol, Juniperus Communis Oil, OriganumMarjorana Oil, Lavandula Officinalis Oil, Rosmarinus Officianalis Oil, ThymusZygis Oil, Tocopherol (Vitamin E), Phenoxyethanol, Ethylhexylglycerin

Methyl Salicylate:

• Indications and usage
• Contraindications
• Warnings
• Precautions
• Adverse reactions
• Overdosage
• Dosage and administration
• How supplied
• Arthrex (Methyl Salicylate) reviews

INDICATIONS AND USAGE

Arthrex (Methyl Salicylate) Cream in combination with 570 to 670 nm wavelength red light illumination using the CureLight BroadBand Model CureLight 01 lamp is indicated for treatment of non-hyperkeratotic actinic keratoses of the face and scalp in immunocompetent patients when used in conjunction with lesion preparation (debridement using a sharp dermal curette) in the physician’s office when other therapies are unacceptable or considered medically less appropriate.

CONTRAINDICATIONS

Arthrex (Methyl Salicylate) Cream is contraindicated in patients with cutaneous photosensitivity, or known allergies to porphyrins, and in patients with known sensitivities to any of the components of Arthrex (Methyl Salicylate) Cream, which includes peanut and almond oil Cream).

This product contains refined peanut oil.

WARNINGS

Arthrex (Methyl Salicylate) Cream is intended for topical use in the physician’s office by trained physicians only. Do not apply to the eyes or to mucous membranes.

Arthrex (Methyl Salicylate) Cream has demonstrated a high rate of contact sensitization (allergenicity). Care should be taken by the physician applying Arthrex (Methyl Salicylate) Cream to avoid inadvertent skin contact. Nitrile gloves should be worn when applying and removing the cream. Vinyl and latex gloves do not provide adequate protection when using this product.Arthrex (Methyl Salicylate) Cream when used with CureLight BroadBand Model CureLight 01 lamp must be used with appropriate protective sleeves obtained from the product manufacturer to decrease the risk of blood-borne transmitted diseases (hepatitis, HIV, etc.). Change the disposable covers for the device (probe and horseshoe positioning device) between patients. Universal Precautions should be used with this treatment.

PRECAUTIONS

The safety and efficacy have not been established for the treatment of cutaneous malignancies and for skin lesions other than non-hyperkeratotic face and scalp actinic keratoses using PDT with Arthrex Cream. Thick (hyperkeratotic) actinic keratoses should not be treated with Arthrex (Methyl Salicylate) Cream. The safety and efficacy of Arthrex (Methyl Salicylate) Cream has not been established in patients with immunosuppression, porphyria or pigmented actinic keratoses.

General

Arthrex (Methyl Salicylate) Cream Application

During the time period between the application of Arthrex (Methyl Salicylate) (methyl aminolevulinate) Cream and exposure to red light illumination, the treatment site will become photosensitive. After Arthrex (Methyl Salicylate) Cream application, patients should avoid exposure of the photosensitive treatment sites to sunlight or bright indoor light (e.g., examination lamps, operating room lamps, tanning beds, or lights at close proximity) during the period prior to red light treatment. Exposure to light may result in a stinging and/or burning sensation and may cause erythema and/or edema of the lesions. Before exposure to sunlight, patients should, therefore, protect treated lesions from the sun by wearing a wide-brimmed hat or similar head covering of light-opaque material. Sunscreens will not protect against photosensitivity reactions caused by visible light. The treated site should be protected from extreme cold with adequate clothing or remaining indoors between application of Arthrex (Methyl Salicylate) and PDT light treatment. After illumination of Arthrex (Methyl Salicylate) Cream, the area treated should be kept covered and away from light for at least 48 hours. Because of the potential for skin to become photosensitized, the Arthrex (Methyl Salicylate) Cream should be used by a trained physician to apply drug only to non-hyperkeratotic actinic keratoses and perilesional skin within 5 mm of the lesion. Redness, swelling, burning, and stinging are expected as a result of therapy; however, if these symptoms increase in severity and persist longer than 3 weeks, the patient should contact their doctor. Metvixia Cream has not been studied for more than two treatment sessions. Information regarding further treatments for residual or new AK lesions performed after 3 months is not available..

Photosensitivity and Device Precautions.

The patient, operator and other persons present should wear protective goggles that sufficiently screen out light with wavelengths from 570 to 670 nm during red light treatment.

If for any reason the patient cannot have the red light treatment after application of Arthrex Cream, the cream should be rinsed off, and the patient should protect the treated area from sunlight, prolonged or intense light for two days. Prolonged exposure for greater than 4 hours to Arthrex (Methyl Salicylate) Cream should be avoided.

Coagulation defects

Arthrex (Methyl Salicylate) Cream has not been tested on patients with inherited or acquired coagulation defects.

Hypersensitivity

Arthrex Cream is formulated with refined peanut and almond oil.

Arthrex (Methyl Salicylate) (methyl aminolevulinate) Cream has not been tested in patients who are allergic to peanuts. Arthrex (Methyl Salicylate) (methyl aminolevulinate) Cream has demonstrated a high rate of contact sensitization (allergenicity). 

Information for Patients

The physician should provide and discuss the attached Patient Package Insert with each patient.

Drug Interactions

There have been no studies of the interaction of Arthrex Cream with any other drugs, including local anesthetics. It is possible that concomitant use of other known photosensitizing agents might increase the photosensitivity reaction of actinic keratoses treated with Arthrex (Methyl Salicylate) Cream.

Carcinogenesis, Mutagenesis, Impairment to Fertility

Long-term studies to evaluate the carcinogenic potential of Arthrex (Methyl Salicylate) Cream have not been performed. 

Arthrex (Methyl Salicylate) aminolevulinate was negative for genetic toxicity in the Ames assay, and the chromosomal aberration assay in Chinese hamster ovary cells, tested with and without metabolic activation and in the presence and absence of light. Arthrex (Methyl Salicylate) aminolevulinate was also negative in the in vivo micronucleus assay in the rat. In contrast, at least one report in the literature has noted genotoxic effects in cultured rat hepatocytes after aminolevulinate (ALA) exposure with PpIX formation. Other studies have documented oxidative DNA damage in vivo and in vitro as a result of ALA exposure. No animal fertility studies have been conducted.

Pregnancy

Teratogenic effects

Pregnancy Category C: Animal reproduction studies have not been conducted with Arthrex Cream. It is also not known whether Arthrex (Methyl Salicylate) Cream can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity.

Arthrex (Methyl Salicylate) Cream should be given to a pregnant woman only if clearly needed.

Nursing Mothers

The amount of Arthrex (Methyl Salicylate) aminolevulinate secreted into human breast milk following topical administration of Arthrex (Methyl Salicylate) Cream is not known. Because many drugs are secreted in human milk, caution should be exercised when Arthrex (Methyl Salicylate) Cream is administered to a nursing mother. If Arthrex (Methyl Salicylate) Cream is used in a nursing mother, a decision should be made whether or not to stop nursing.

Pediatric Use

It is not recommended that Arthrex Cream be used in pediatric patients. Actinic keratosis is rarely found in pediatric patients. 

Geriatric Use

Seventy percent (269 among 383) of the patients treated with Arthrex (Methyl Salicylate) Cream in all clinical studies of actinic keratosis were 65 years of age or older. No overall differences in safety and efficacy were observed between patients aged 65 years and older and those who were younger.

ADVERSE REACTIONS

Dermal Safety Studies

Provocative studies to evaluate irritancy and sensitization have demonstrated that Arthrex Cream is an irritant and sensitizer. A provocative cumulative irritancy and sensitization (allergenicity) study of Arthrex (Methyl Salicylate) Cream with a cross-sensitization challenge with ALA was performed in 156 subjects. Only 98 of the 156 subjects tested entered the challenge phase. Fifty-two percent of the subjects (30/58), who agreed to challenge with Arthrex (Methyl Salicylate) Cream, were positive (sensitized). Forty subjects refused challenge with Arthrex (Methyl Salicylate) Cream and 60 withdrew. At least 58 of the 60 subjects who withdrew from the study discontinued due to irritation/sensitization.

Ninety-eight subjects agreed to challenge with ALA. Two percent of the ALA challenged subjects (2/98) were scored as equivocal reactions and 2% in the paraffin vehicle group were scored as positive.

Adverse Events

In vehicle-controlled phase 3 studies of actinic keratosis, 88% of patients treated with Arthrex (Methyl Salicylate) Cream reported one or more adverse events.

Burning was the most frequent complaint, reported by 50% of patients (ranging from mild, to severe) and 9% of those patients reported severe burning sensation. Pain in the skin was reported by 21% of patients and 7% had severe pain. Local erythema lasting up to two weeks and edema up to one week after treatment were reported by 31% and 6% of patients. Symptoms and signs of local phototoxicity were observed in 88% of patients treated with Arthrex (Methyl Salicylate) Cream in all clinical studies of Arthrex (Methyl Salicylate) -PDT for actinic keratoses.

The majority of patients in all the clinical trials had local pain or discomfort upon illumination. There were 4 (1.0%) withdrawals/discontinuations among 383 patients treated with Arthrex (Methyl Salicylate) Cream in all the clinical trials of actinic keratosis, all of which were due to the adverse event of local pain on illumination.

There have been reported instances of patients treated with Arthrex (Methyl Salicylate) Cream (2 out of 130) who have developed squamous cell and basal cell carcinoma at the site of treatment. The relationship to treatment with Arthrex (Methyl Salicylate) Cream is unknown. Serious erythema and facial edema have been described in European post-marketing reports.

OVERDOSAGE

Arthrex Cream Overdose

Arthrex (Methyl Salicylate) Cream overdose has not been reported. If the patient for any reason cannot have the red light treatment during the prescribed period after application (the 3 hour timespan), the cream should be rinsed off, and the patient should protect the exposed area from sunlight, prolonged or intense light for two days.  

Red Light Overdose

There is no information on overdose of red light following Arthrex (Methyl Salicylate) Cream application.

In case of red light overexposure and skin burn occurs, the patient should be treated according to standard of practice guidelines for treatment of cutaneous burns.

DOSAGE AND ADMINISTRATION

Photodynamic therapy for non-hyperkeratotic actinic keratoses with Arthrex (Methyl Salicylate) Cream is a multi-stage process as described below: Two treatment sessions 7 days apart should be conducted. Not more than one gram (half a tube) of Arthrex (Methyl Salicylate) Cream should be applied per treatment session.

One Arthrex (Methyl Salicylate) -PDT session consists of: 1) Lesion debriding –

Before applying Arthrex (Methyl Salicylate) Cream, the surface of the lesions should be prepared with a small dermal curette to remove scales and crusts and roughen the surface of the lesion. This is to facilitate access of the cream and light to all parts of the lesion.

Figure 1 A Lesion debriding  Only nitrile gloves should be worn during this and subsequent steps and Universal Precautions should be taken. Vinyl and latex gloves do not provide adequate protection when using this product.

Figure 1B Lesion debriding2) Application of Arthrex (Methyl Salicylate) Cream –

Using a spatula, apply a layer of Arthrex (Methyl Salicylate) Cream about 1 mm thick to the lesion and the surrounding 5 mm of normal skin. Do not apply more than one gram of Arthrex (Methyl Salicylate) Cream for each patient per treatment session.

Figure 2: Cream applicationThe area to which the cream has been applied should then be covered with an occlusive, non-absorbent dressing for 3 hours. Multiple lesions may be treated during the same treatment session. Each treatment field is limited to a diameter of 55 mm. Only nitrile gloves should be worn by the qualified healthcare provider in order to avoid skin contact with the cream. This product is not intended for application by patients or unqualified medical personnel.

Figure 3: Occlusive dressing application3) Wait for 3 hours - (at least 2.5 hours, but no more than 4 hours).

After Cream application, patients should avoid exposure of the photosensitive treatment sites to sunlight or bright indoor light (e.g., examination lamps, operating room lamps, tanning beds, or lights at close proximity) during the period prior to red light treatment. Exposure to light may result in a stinging and/or burning sensation and may cause erythema and/or edema of the lesions. Patients should protect treated areas from the sun by wearing a wide-brimmed hat or similar head covering of light-opaque material. Sunscreens will not protect against photosensitivity reactions caused by visible light. It has not been determined if perspiration can spread the Arthrex (Methyl Salicylate) Cream outside the treatment site to the eyes or surrounding skin. The treated site should be protected from extreme cold with adequate clothing or remaining indoors between application of Arthrex (Methyl Salicylate) Cream and PDT light treatment.4) Removal of Dressing and Rinse Off Excess Cream - Following removal of the occlusive dressing, clean the area with saline and gauze. Nitrile gloves should be worn at this step by the trained physician. 

Figure 4: Cream removal5) Illumination of Arthrex (Methyl Salicylate) Treated Lesion - It is important to ensure that the correct light dose is administered. The light intensity at the lesion surface should not be higher than 200 mW/cm². Patient and operator should adhere to safety instructions and Universal Precautions provided with the lamp. The patient and operator should wear protective goggles during illumination. Patients should be advised that transient stinging and/or burning at the target lesion sites may occur during the period of light exposure.

Figure 5: IlluminationThe CureLight BroadBand Model CureLight 01 lamp is approved for the use in Arthrex (Methyl Salicylate) -PDT. The lamp should be carefully calibrated so that dosing is accurate and immediately thereafter the lesion should be exposed to red light with a continuous spectrum of 570 to 670 nm and a total light dose of 75 J/cm². To avoid direct contact between lamp parts and patient skin, always use disposable protective plastic sleeves on the positioning device and on the light measuring probe. Following each patient treatment, the disposable protective plastic sleeves should be removed from the positioning device and from the light measuring probe and discarded. If red light treatment is interrupted or stopped for any reason, it may be restarted. If the patient for any reason cannot have the red light treatment during the prescribed period after application (the 3 hour timespan), the cream should be rinsed off and the patient should protect the exposed area from sunlight, prolonged or intense light for two days. Arthrex (Methyl Salicylate) Cream is not intended for use with any device other than the approved lamp: CureLight BroadBand Model CureLight 01. Use of Arthrex (Methyl Salicylate) Cream without subsequent red light illumination is not recommended. No more than 1 gram (half a tube) of product should be used for each of the two weekly treatment sessions. Multiple lesions may be treated during the same treatment session using a total of 1 gram of Arthrex (Methyl Salicylate) Cream. Lesion response should be assessed 3 months after the last treatment session.   This product is not intended for application by patients or unqualified medical personnel, therefore, this product is only dispensed to physicians.

HOW SUPPLIED

Arthrex Cream, 16.8%, is available as the following:

NDC 63069-401-01, 2 gram aluminum tube, box of 1

Product Package

Keep out of reach of children

For topical use only by physicians in the physician’s office. Rx Only

Storage Conditions

Store refrigerated, 2-8°C.

Use contents within one week after opening.

Should not be used after 24 hours out of refrigerator.

Metvixia Cream is a registered trade name of PhotoCure ASA.

PhotoCure ASA, Hoffsveien 48, N-0377 Oslo, Norway

USA Contact: Cato Research, Westpark Corporate Center, 4364 South Alston Avenue, Durham NC 27713

Revision: September 5, 2007

PATIENT INFORMATION

Arthrex (Methyl Salicylate)^™ Cream 16.8% (phonetic)

Generic name: Arthrex (Methyl Salicylate) aminolevulinate hydrochloride

Read this Patient Information before you get treated with Arthrex (Methyl Salicylate) Cream and each time you get a treatment. There may be new information. This leaflet does not take the place of talking with your doctor about your condition or treatment. Ask your healthcare provider about anything you do not understand about Arthrex (Methyl Salicylate) Cream.

What is the most important thing I need to know about Arthrex Cream?

• Arthrex (Methyl Salicylate) Cream with light treatment (Photodynamic therapy or PDT) is only done in medical offices by trained doctors.
• Arthrex (Methyl Salicylate) Cream is not applied by patients. Arthrex (Methyl Salicylate) Cream should not be applied by doctors who have not been trained in its use.

What is Arthrex Cream?

Arthrex (Methyl Salicylate) Cream is a prescription cream used with PDT (light treatment) to treat skin growths on the face and scalp called actinic keratosis (AK). Arthrex (Methyl Salicylate) Cream is only used for AK skin growths that are thin and not dark colored. AK skin growths are not cancer. AK skin growths are caused partly by too much sun exposure. Arthrex (Methyl Salicylate) Cream and PDT work together to treat AK skin growths.

Arthrex (Methyl Salicylate) Cream has not been studied in children for any condition and should not be used in children.

Who should not use Arthrex Cream?

Do not use Arthrex (Methyl Salicylate) Cream if:

• your skin over reacts to sun or light (photosensitivity)
• you are allergic to porphyrins or to any of the ingredients in Arthrex (Methyl Salicylate) Cream. The active ingredient is Arthrex (Methyl Salicylate) aminolevulinate hydrochloride. Arthrex (Methyl Salicylate) Cream also contains peanut and almond oil. See the end of this leaflet for a complete list of ingredients in Arthrex (Methyl Salicylate) Cream.

Before treatment with Arthrex Cream, tell your doctor:

• about your medical conditions, including if you
  • are pregnant or planning to become pregnant. It is not known if Arthrex (Methyl Salicylate) Cream can harm your unborn baby.
  • are breastfeeding. It is not known if Arthrex (Methyl Salicylate) Cream passes into your milk and if it can harm your baby. You should decide whether or not to stop breastfeeding while getting treatment with Arthrex (Methyl Salicylate) Cream. Talk to your doctor for help with this choice.
  • are allergic to nuts or peanuts
  • have or had skin cancer or other skin growths on your body
  • have bleeding problems.
• about all the medicines you take, including prescription and non-prescription medicines, vitamins and herbal supplements. It is not known if Arthrex (Methyl Salicylate) Cream and other medicines can affect each other.

How should I use Arthrex Cream?

• Arthrex (Methyl Salicylate) Cream and PDT treatment is only done by trained doctors.
• You will receive 2 treatments with Arthrex (Methyl Salicylate) Cream and PDT 7 days (1 week) apart. Your doctor will check you three months after treatment to see if the treatment worked for you. Cream and PDT.”)
• Arthrex (Methyl Salicylate) Cream is for skin use only. Do not get Arthrex (Methyl Salicylate) Cream in your eyes, mouth, or nose. Tell your doctor right away if this happens.

What should I avoid while using Arthrex Cream?

During the 3 hours that Arthrex (Methyl Salicylate) Cream is on your skin:

• Avoid exposure to sunlight or bright indoor light during the 3 hours that Arthrex (Methyl Salicylate) Cream is on your skin. Wear a protective hat and clothing if you need to be outside in the sun.
• Avoid exposure to cold temperatures during the 3 hours that Arthrex (Methyl Salicylate) Cream is on your skin. Wear warm clothing and keep your treated skin site covered if you are in cold temperatures.

• Carefully rinse off the Cream.
• Avoid exposure to sunlight, prolonged or intense light for two days after treatment.

What are the possible side effects of Arthrex Cream with PDT treatment?

Common side effects of Arthrex (Methyl Salicylate) Cream with PDT treatment include the following skin reactions at the treated site:

• burning feeling
• redness
• pain
• stinging
• swelling
• crusting, peeling, blisters, bleeding, itching, ulcers
• infection

General information about Arthrex Cream

Medicines are sometimes prescribed for conditions that are not mentioned in patient information leaflets.

This leaflet summarizes the most important information about Arthrex (Methyl Salicylate) Cream. If you would like more information, talk with your doctor. You can ask your doctor for information about Arthrex (Methyl Salicylate) Cream that is written for health professionals. Toll-free number and/or website will be provided when available for the US market.

What are the ingredients in Arthrex Cream?

Active Ingredient: Arthrex (Methyl Salicylate) aminolevulinate hydrochloride

Other Ingredients: Glyceryl monostearate, cetostearyl alcohol, poloxyl stearate, cholesterol, oleyl alcohol glycerin, white petrolatum, isopropyl myristate, refined peanut oil, refined almond oil, edetate disodium, methylparaben and propylparaben. The color of the product is cream to pale yellow.

Treatment with Arthrex Cream and PDT

Figure 1: Lesion debriding

Your doctor will prepare your skin by gently scraping (debriding) your skin growths before treating with Arthrex (Methyl Salicylate) Cream and PDT. A small skin scraper is used to remove scales and crusts and to roughen the surface of any skin growths. This is to help Arthrex (Methyl Salicylate) Cream and PDT to reach all parts of the skin growths.

Figure 2: Cream application Metvixia Cream is applied to the actinic keratosis skin growths and to a small area of the skin around the growths.

Figure 3: Clear bandage application The treated skin areas will be covered with a special clear bandage for about 3 hours.

During these 3-hours you should avoid exposure of treated area to sunlight or bright indoor light. Exposure to light may make your treated skin area sting or burn. Your treated skin area may turn red or swell (photosensitive reactions). Wear a hat and protective clothes if you are exposed to sunlight during this time. Sunscreens will not help protect your treated skin during this time. In cold weather, your treated skin site should be protected from the cold with warm clothes or you should stay indoors for these 3 hours between the cream and light treatment.

Figure 4: Cream removal The clear bandage will be removed and the area will be rinsed with a saline solution before the PDT (light) treatment.

Figure 5: IlluminationThe skin growth will be treated with PDT. PDT lasts about 10 minutes for each area treated with the lamp. You will wear protective goggles to cover your eyes during this part of the treatment. More than 1 skin growth may be treated at a time. Your treated skin areas may burn, feel painful, sting, or tingle during light treatment. These symptoms may last for a few hours after the treatment. If you cannot have the light treatment 3 hours after Arthrex (Methyl Salicylate) Cream is applied, rinse the cream off your skin and you must protect your skin from sunlight and bright indoor light for 2 days. This product should only be stored in refrigerators in pharmacies and medical offices. Rx only

Arthrex (Methyl Salicylate) Cream is a registered trade name of PhotoCure ASA.

Sponsor: PhotoCure ASA, Hoffsveien 48, NO-0377 Oslo, Norway

U.S. Contact: Cato Research, Westpark Corporate Center, 4364 South Alston Avenue, Durham NC 27713

Manufacturer: Penn Pharmaceutical Services Ltd., Tafarnaubach Industrial Estate, Tredegar, Gwent, NP22 3AA, UK.

Salicylic Acid:

• Pharmacological action
• Why is Arthrex (Salicylic Acid) prescribed?
• Dosage and administration
• Arthrex (Salicylic Acid) side effects, adverse reactions
• Arthrex contraindications
• Special instructions
• Arthrex drug interactions
• Arthrex (Salicylic Acid) reviews

Pharmacological action

Arthrex is pharmaceytical active ingredient for topical use. Inhibits the secretion of the sebaceous and sweat glands. At low concentrations it has keratoplastic and in high doses keratolytic effect. Arthrex (Salicylic Acid) has a weak antimicrobial activity.

Why is Arthrex (Salicylic Acid) prescribed?

Monotherapy with Arthrex (Salicylic Acid) and as part of combination therapies for inflammatory, infectious and other skin lesions, including burns, psoriasis, eczema, dyskeratosis, ichthyosis, acne vulgaris, warts, hyperkeratosis, corn, callus, oily seborrhea, scaly skin disease, hair loss, sweating feet.

Dosage and administration

Arthrex is applied to the skin surface 2-3 times / day.

Arthrex (Salicylic Acid) side effects, adverse reactions

Rarely: local reactions such as itching, burning, skin rashes, allergic reactions.

Arthrex contraindications

Hypersensitivity to Arthrex (Salicylic Acid), renal failure, infancy.

Special instructions

The composition of the solution for topical use include ethanol.

Arthrex drug interactions

Arthrex (Salicylic Acid) is pharmaceutically not compatible with resorcinol (forms melted mixture) and zinc oxide (forms insoluble forms of zinc salicylate).