SALICYLIC ACID- salicylic acid lotion

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ)

Available from:

Nationwide Laboratories, LLC

INN (International Name):

SALICYLIC ACID

Composition:

SALICYLIC ACID 6 g in 100 mL

Administration route:

TOPICAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

For Dermatologic  Use: Salicylic Acid 6% 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% 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. Salicylic Acid 6% should not be used in any patient known to be sensitive to salicylic acid or any other listed ingredients. Salicylic Acid 6% should not be used in children under 2 years of age.

Product summary:

Salicylic Acid 6% Cream is available in 16 oz (454 g) bottles, NDC 42937-711-16 Salicylic Acid 6% Lotion is available in 16 fl. oz (473 mL) bottles, NDC 42937-712-16 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. Protect from freezing.

Authorization status:

unapproved drug other

Summary of Product characteristics

SALICYLIC ACID- SALICYLIC ACID LOTION
NATIONWIDE LABORATORIES, LLC
_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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FOR DERMATOLOGICAL USE ONLY.
NOT FOR OPHTHALMIC, ORAL OR INTRAVAGINAL USE.
INGREDIENTS
SALICYLIC ACID 6% CREAM contains 6% salicylic acid USP incorporated
into a specially formulated oil
and water emulsion vehicle consisting of Ammonium Lactate, Cetyl
Alcohol, Dimethicone, Disodium
EDTA, Glycerin, Methyl Paraben, Mineral Oil, PEG-100 , Phenoxy
Ethanol, Polysorbate – 80, Propyp
Paraben, Trolamine, Water
SALICYLIC ACID 6% LOTION contains 6% w/w salicylic acid USP
incorporated into a specially formulated
oil and water emulsion vehicle consisting of Ammonium lactate, Cetyl
Alcohol, Cetearyl alcohol,
Dimethicone, Disodium EDTA, Glycerin, Glyceryl Stearate, Methyl
Paraben, Mineral Oil, PEG-100,
Phenoxy Ethanol, Polysorbate-80, Propyl Paraben, Trolamine , Water
DESCRIPTION
Salicylic acid is the 2-hydroxy derivative of benzoic acid having the
following structure:
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. The mechanism of action has
been attributed to a dissolution of intercellular cement substance. 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 Halprin 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 extrace