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SALICYLIC ACID GEL 0.06 40 GM - 60 mg/g GEL
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SALICYLIC ACID GEL 0.06 40 GM

Generic: SALICYLIC ACID

SALICYLIC ACID GEL 0.06 40 GM

NDC:42192-0134-40
Manufacturer:Acella Pharmaceuticals, LLC
Strength:60 mg/g
Dosage Form:GEL
Route:TOPICAL

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Drug Information

Identification

Generic Name

SALICYLIC ACID

Brand Name

Salicylic Acid

Labeler / Distributor

Acella Pharmaceuticals, LLC

Product Type

HUMAN PRESCRIPTION DRUG

Administration

Dosage Form

GEL

Route of Administration

TOPICAL

Active Ingredients

IngredientStrength
SALICYLIC ACID60 mg/g

Data sourced from openFDA / DailyMed. For full prescribing information, consult the drug label.

Clinical Drug Information

Indications & Usage

INDICATIONS AND USAGE For the removal of excess keratin in hyperkeratotic disorders, including scaling associated with psoriasis or thickened skin of palms and soles, corns and calluses.

Warnings

WARNINGS Contact with eyes, lips, broken or inflamed skin, and all mucous membranes should be avoided. Prolonged use over large areas, especially in children and those patients with significant renal or hepatic impairment could result in salicylism. Concomitant use of other 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, hyperpnoea, diarrhea, psychic disturbances. In the event of salicylic acid toxicity, the use of Salicylic Acid 6% Gel should be discontinued. Fluids should be administered to promote urinary excretion. Treatment with sodium bicarbonate (oral or intravenous) should be instituted as appropriate. Considering the potential of developing Reye’s syndrome, salicylate products should not be administered to children or teenagers with varicella or influenza, unless directed by a physician.

Dosage & Administration

DOSAGE AND ADMINISTRATION The preferable method of use is to apply Salicylic Acid 6% Gel thoroughly to the affected area and occlude the area at night. 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% Gel will usually maintain the remission. In those areas where occlusion is difficult or impossible, application may be made more frequently; hydration by wet packs or baths prior to application apparently enhances the effect. Unless hands are being treated, hands should be rinsed thoroughly after application.

Adverse Reactions

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

Clinical data sourced from openFDA drug labeling. For complete prescribing information, consult the full drug label.