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Name:Salicylic Acid
Manufacturer:Metacon Labs
Category:Prescription Marketed Drugs


Salicylic Acid

SALICYLIC ACID - salicylic acid aerosol, foam 
Metacon Labs

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

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Salicylic Acid

DESCRIPTION

Salicylic Acid 6% Emollient Foam is a keratolytic that contains 6% salicylic acid USP incorporated into an aqueous based ammonium lactate vehicle. Each gram of Salicylic Acid 6% Emollient Foam contains 6% w/w salicylic acid USP, aloe, ammonium lactate, ceteth-10 phosphate, ceteth-20 phosphate, cetostearyl alcohol NF, dicetyl phosphate, dl alpha tocopheryl acetate USP, edetate disodium dihydrate USP, glycerin USP, methylparaben NF, propylene glycol USP, propylparaben NF, purified water USP, sodium hydroxide NF, white petrolatum USP.

Also contains: Propellant HFA-134a(1,1,1,2-tetrafluo-roethane).

Salicylic Acid USP is the 2-hydroxy derivative of benzoic acid having the following Structure:

Salicylic acid

CLINICAL PHARMACOLOGY

Salicylic acid has been shown to produce desquamation of the horny layer of skin while not effecting qualitative or quantitative changes in the structure of the viable epidermis.1,2 The meachanism of action has been attributed to a dissolution of intercellular cement substance.3 In a study of the percutaneous absorption of salicylic acid in a 6% salicylic acid gel in four patients with extensive active psoriasis, Taylor and Halprin4 showed that the peak serum salicylate levels never exceeded 5 mg/100 ml even though more than 60% of the applied salicylic acid was absorbed. Systemic toxic reactions are usually associated with much higher serum levels (30 to 40 mg/100 ml). Peak serum levels occurred within five hours of the topical application under occlusion. The sites were occluded for 10 hours over the entire body surface below the neck. Since salicylates are distributed in the extracellular space, patients with a contracted extracellular space due to dehydration or diuretics have higher salicylate levels than those with a normal extracellular space.5 (See PRECAUTIONS.)

The major metabolites identified in the urine after topical administration are salicyluric acid (52%), salicylate glucuronides (42%) and free salicylic acid (6%).4 The urinary metabolites after percutaneous absorption differ from those after oral salicylate administration; those derived from percutaneous absorption contain more salicylate glucuronides and less salicyluric and salicylic acid. Almost 95% of a single dose of salicylate is excreted within 24 hours of its entrance into the extracellular space.5

Fifty to eighty percent of salicylate is protein bound to albumin. Salicylates compete with the binding of several drugs and can modify the action of these drugs; by similar competitive mechanisms other drugs can influence the serum levels of salicylate.5 (See WARNINGS.) Ammonium lactate, a salt of lactic acid, is a powerful humectant with exfoliating properties.

INDICATIONS AND USAGE

For Dermatologic Use: Salicylic Acid 6% Emollient Foam is a topical aid in the removal of excessive keratin in hyperkeratotic skin disorders, including verrucae, and the various ichthyoses (vulgaris, sex-linked and lamellar), keratosis palmaris and plantaris, keratosis pilaris, pityriasis rubra pilaris, and psoriasis (including body, scalp, palms and soles).

For Podiatric Use: Salicylic Acid 6% Emollient Foam is a topical aid in the removal of excessive keratin on dorsal and plantar hyperkeratotic lesions. Topical preparations of 6% salicylic acid have been reported to be useful adjunctive therapy for verrucae plantares.

CONTRAINDICATIONS

Salicylic Acid 6% Emollient Foam should not be used in any patient known to be sensitive to salicylic acid or any other listed ingredient. Salicylic Acid 6% Emollient Foam should not be used in children under 2 years of age.

WARNINGS

Prolonged and repeated daily use over large areas, especially in children and those patients with significant renal or hepatic impairment, could result in salicylism. Excessive application of the product other than is needed to cover the affected area will not result in a more rapid therapeutic benefit. Concomitant use of others drugs which may contribute to elevated serum salicylate levels should be avoided where the potential for toxicity is present. In children under 12 years of age and those patients with renal or hepatic impairment, the area to be treated should be limited and the patient monitored closely for signs of salicylate toxicity: nausea, vomiting, dizziness, loss of hearing, tinnitus, lethargy, hyperpnea, diarrhea, and psychic disturbances. In the event of salicylic acid toxicity, the use of Salicylic Acid 6% Emollient Foam should be discontinued. Fluids should be administered to promote urinary excretion. Treatment with sodium bicarbonate (oral or intravenous) should be instituted as appropriate. Patients should be cautioned against the use of oral aspirin and other salicylate containing medications, such as sports injury creams, to avoid additional excessive exposure to salicylic acid. Where needed, aspirin  should be replaced by an alternative non-steroidal anti-inflammatory agent that is not salicylate based.

Due to potential risk of developing Reye's syndrome, salicylate products should not be used in children and teenagers with varicella or influenza, unless directed by a physician.

Keep out of the reach of children. Contents under pressure. Do not puncture or incinerate container. Do not expose to temperatures above 120°F (49°C).

FOR DERMATOLOGICAL USE ONLY. NOT FOR OPTHALMIC, ORAL OR INTRAVAGINAL USE.

PRECAUTIONS

For EXTERNAL USE ONLY. Avoid contact with eyes and other mucous membranes. Mild burning or stinging may occur. Peeling of the skin may increase as the salicylic acid works to loosen excessive keratin. If excessive burning, stinging or peeling occurs, discontinue use and consult your physician. Keep this and all medications out of reach of children.

DRUG INTERACTIONS

The following interactions are from a published review5 and include reports concerning both oral and topical salicylate administration. The relationship of these interactions to the use of Salicylic Acid 6% Emollient Foam is not known. 

I. Due to the competition of salicylate with other drugs for binding to serum albumin the following drug interactions may occur:
 DRUG  DESCRIPTION OF INTERACTION
 Tolbutamide; Sulfonylureas  Hypoglycemia potentiated.

 Methotrexate

 

 Decreases tubular reabsorption; clinical toxicity from

 methotrexate can result.

 Oral Anticoagulants  Increased bleeding.
II. Drugs changing salicylate levels by altering renal tubular reabsorption:
 DRUG  DESCRIPTION OF INTERACTION
 Corticosteroids

 Decreases plasma salicylate level; tapering doses of

 steroids may promote salicylism.

 Acidifying Agents  Increases plasma salicylate level.
 Alkanizing Agents  Decreased plasma salicylate levels.
III. Drugs with complicated interactions with salicylates:
 DRUG   DESCRIPTION OF INTERACTION
 Heparin

 Salicylate decreases platelet adhesiveness and interferes

 with hemostasis in heparin treated patients.

 Pyrazinamide  Inhibits pyrazinamide induced hyperuricemia.
 Uricosuric Agents

 Effect of probenemide, sulfinpyrazone and phenylbultazone

 inhibited.

The following alterations of laboratory tests have been reported during salicylate therapy6

 LABORATORY TESTS  EFFECT OF SALICYLATES 
 Thyroid Function  Decreased PBI; increased T3 uptake.
 Urinary Sugar

 False negative with glucose oxidase; False positive with

 Clinitest with high-dose salicylate therapy (2-5g q.d.).

 5-Hydroxyindole acetic acid  False negative with fluorometric test. 
 Acetone ketone bodies

 False positive FeCl3 in Gerhardt reaction; red color

 persists with boiling.

 17-OH corticosteroids  False reduced values with >4.8g q.d. Salicylate. 
 Vanilmandelic acid  False reduced values. 
 Uric acid  May increase or decrease depending on dose. 
 Prothrombin  Decreased levels; slightly increased prothrombin time.

PREGNANCY (Category C)

Salicylic acid has been shown to be teratogenic in rats and monkeys. It is difficult to extrapolate from oral doses of acetylsalicylic acid used in these studies to topical administration as the oral dose to monkeys may represent six times the maximal daily human dose of salicylic acid when applied topically over a large body surface. There are no adequate and well-controlled studies in pregnant women. Salicylic Acid 6% Emollient Foam should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Nursing Mothers

Because of the potential for serious adverse reactions in nursing infants from the mother's use of Salicylic Acid 6% Emollient Foam, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother. If used by nursing mothers, it should not be used on the chest area to avoid the accidental contamination of the child.

Carcinogenesis, Mutagenesis, Impairment of Fertility

No data are available concerning potential carcinogenic or reproductive effects of Salicylic Acid 6% Emollient Foam. Salicylic acid has been shown to lack mutagenic potential in the Ames Salmonella test.

ADVERSE REACTIONS

Excessive erythema and scaling conceivably could result from use on open skin lesions.

OVERDOSAGE

See Warnings.

DOSAGE AND ADMINISTRATION

Important: Prime Can Before Initial Use.

To Prime can: Grasp can in one hand. Shake can vigorously (until product moves inside can). Firmly strike bottom of can onto palm of other hand or a hard surface at least 3 times. Hold can upright and direct initial spray to a non-skin surface, such as into cap of can. DO NOT spray directly on the skin as the initial spray may expel cold, liquid propellant. Press down on actuator for 1 to 3 seconds until foam begins to dispense. If foam does not dispense within 3 seconds, prime can again.

Before Each Use: Shake can vigorously. Firmly strike bottom of can onto palm of other hand or a hard surface at least 3 times.

During Use: Holding can upright, dispense Salicylic Acid 6% Emollient Foam into palm of hand and apply thoroughly to affected area twice per day, or as directed by a physician. Rub in completely. Wipe off any excess foam from actuator after use. The preferable method of use is to apply Salicylic Acid 6% Emollient Foam thoroughly to the affected area and to cover the treated area at night, after washing and before retiring. Preferably, the skin should be hydrated for at least five minutes prior to application. The medication is washed off in the morning and if excessive drying and/or irritation is observed a bland cream or lotion may be applied. Once clearing is apparent, the occasional use of Salicylic Acid 6% Emollient Foam will usually maintain the remission. In those areas where the placement of a protective covering is difficult or impossible, application of Salicylic Acid 6% Emollient Foam may be made more frequently; hydration by wet packs or baths prior to application apparently enhances the effect. (See WARNINGS.) Unless hands are being treated, hands should be rinsed thoroughly after application. Excessive repeated application of Salicylic Acid 6% Emollient Foam will not necessarily increase its therapeutic benefit, but could result in increased local intolerance and systemic adverse effects such as salicylism. 

HOW SUPPLIED

Salicylic Acid 6% Emollient Foam is supplied in 60g (NDC# 49808-167-60) aluminum cans.

Store at room temperature 59° - 77°F (15° - 25°C).

Protect from freezing.

Store upright.

REFERENCES

  1. Davies M, Marks R: Br J Dermatol 95: 187–192, 1976.
  2. Marks R, Davies M, Cattel A: J Invest Dermatol 64: 283, 1975.
  3. Huber C, Christophers E: Arch Derm Res 257: 293-297, 1977.
  4. Taylor JR, Halprin KM: Arch Dermatol 111: 740-743, 1975. 
  5. Goldsmith LA: Int J Dermatol 18: 32-36, 1979.
  6. Wilson JG, Ritter EJ, Scott WJ, Fradlein R: Tox Appl Pharmacol 41: 67-78, 1977.

Manufactured for :

Metacon Labs

866-777-4633

www.metaconlabs.com

Metacon Labs 

Patent Pending

P/N 2619 Rev. 0

Salicylic acid label

Rx only

Salicylic Acid 6% 

Emollient Foam

In An Ammonium Lactate Vehicle

NDC 49808-167-60

Net Weight 60g

Salicylic acid carton


SALICYLIC ACID 
salicylic acid aerosol, foam
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:49808-167
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SALICYLIC ACID (SALICYLIC ACID) SALICYLIC ACID 6 g  in 100 g
Inactive Ingredients
Ingredient Name Strength
PROPYLENE GLYCOL  
CETOSTEARYL ALCOHOL  
ALPHA-TOCOPHEROL ACETATE  
METHYLPARABEN  
PROPYLPARABEN  
WATER  
PETROLATUM  
GLYCERIN  
EDETATE SODIUM  
ALOE  
SODIUM HYDROXIDE  
AMMONIUM LACTATE  
Product Characteristics
Color      Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:49808-167-60 1 CAN (1 CAN) in 1 CARTON contains a CAN
1 60 g in 1 CAN This package is contained within the CARTON (49808-167-60)

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
Unapproved drug other 08/01/2010

Labeler - Metacon Labs (793223707)
Registrant - Onset Dermatologics LLC (964275155)
Establishment
Name Address ID/FEI Operations
Metacon Labs 793223707 Manufacture

Revised: 06/2011 Metacon Labs



Source: http://dailymed.nlm.nih.gov
Reproduced with permission of U.S. National Library of Medicine


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