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:

Perrigo New York Inc

INN (International Name):

SALICYLIC ACID

Composition:

SALICYLIC ACID 6 mg in 100 mL

Prescription type:

PRESCRIPTION DRUG

Authorization status:

unapproved drug other

Summary of Product characteristics

SALICYLIC ACID- SALICYLIC ACID LOTION
SALICYLIC ACID- SALICYLIC ACID CREAM
PERRIGO NEW YORK INC
_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 CREAM, 6% SALICYLIC ACID LOTION, 6%
RX ONLY
FOR DERMATOLOGICAL USE ONLY. NOT FOR OPHTHALMIC, ORAL OR
INTRAVAGINAL USE.
DESCRIPTION
Salicylic Acid Cream, 6% contains 6% salicylic acid USP incorporated
into an emulsion vehicle
consisting of ammonium lactate, behentrimonium chloride and isopropyl
alcohol, cetyl alcohol,
dimethicone 350, disodium EDTA, glycerin, glyceryl stearate SE,
methylparaben, mineral oil, PEG-100
stearate, phenoxyethanol, propylparaben, purified water, stearyl
alcohol and trolamine.
Salicylic Acid Lotion, 6% contains 6% w/w salicylic acid USP
incorporated into an emulsion vehicle
consisting of ammonium lactate, behentrimonium chloride and isopropyl
alcohol, cetyl alcohol,
dimethicone 350, disodium EDTA, glycerin, glyceryl stearate SE,
methylparaben, mineral oil, PEG-100
stearate, propylparaben, purified water, stearyl alcohol and
trolamine. 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 occl