Drug Catalog - Product Detail
SALICYLIC ACID CREAM KIT (WITH PRUDRATE HYDRATING CLEANSER) KIT 0.06 454GM/12OZ
| NDC | Mfr | Size | Str | Form |
|---|---|---|---|---|
| 42546-0270-01 | PRUGEN | 1 | 6% CREAM | NA |
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Description
DESCRIPTION Salicylic Acid 6% (w/w) Cream contains salicylic acid, USP 6% in a cream base composed of ammonium lactate, cetearyl alcohol, cetearyl alcohol (and) PEG-3 distearoylamidoethylmonium methosulfate (and) polysorbate 60, cetyl alcohol, dimethicone 350, disodium EDTA, glycerine, glyceryl stearate SE, methylparaben, mineral oil, PEG-100 stearate, phenoxyethanol, propylparaben, purified water and trolamine. Salicylic acid is the 2-hydroxy derivative of benzoic acid having the following structure: This formulation has been shown to provide gradual and prolonged release of the active ingredient into the skin. Chemical Structure
How Supplied
HOW SUPPLIED Salicylic Acid 6% (w/w) Cream Kit includes a 16 oz. (454 g) jar with Salicylic Acid 6% (w/w) Cream (NDC 42546-270-16) as well as a complimentary 12 fl. oz. PruDrate Hydrating Cleanser. Store at 20°C to 25°C (68°F to 77°F), excursions permitted between 15°C and 30°C (between 59°F and 86°F). Brief exposure to temperatures up to 40°C (104°F) may be tolerated provided the mean kinetic temperature does not exceed 25°C (77°F); however, such exposure should be minimized. Do not freeze.
Indications & Usage
INDICATIONS AND USAGE For Dermatologic Use Salicylic Acid 6% (w/w) Cream 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% (w/w) Cream is a topical aid in the removal of excessive keratin on the dorsal and plantar hyperkeratotic lesions. Topical preparations of 6% salicylic acid have been reported to be useful adjunctive therapy for verrucae plantares.
Dosage and Administration
DOSAGE AND ADMINISTRATION The preferable method of use is to apply 6% Salicylic Acid (w/w) Cream 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% (w/w) Cream 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. (See WARNINGS .) Unless hands are being treated, hands should be rinsed thoroughly after application. Excessive repeated application of Salicylic Acid 6% (w/w) Cream will not necessarily increase its therapeutic benefit, but could result in increased local intolerance and systemic adverse effects such as salicylism.
