Salicylic Acid (Page 2 of 2)

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 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, 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 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

The preferable method of use is to apply Salicylic Acid 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 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 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 Cream, 6% is available in 400g

(NDC 45802-806 -01) bottles.

Salicylic Acid Lotion, 6% is available in 14 fl oz (414 ml)

(NDC 45802-818 -41) bottles.

Store at controlled room temperature 20° — 25°C (68° — 77°F). Do not freeze.

MADE IN ISRAEL

MANUFACTURED BY

PERRIGO

YERUHAM, ISRAEL 80500

Perrigo

: 5C200 RC J1

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL

Salicylic Acid Lotion, 6%

Rx Only

Salicylic Acid Lotion, 6% Front Label
(click image for full-size original)

Salicylic Acid Lotion, 6% Front Label

Salicylic Acid Lotion, 6% Back Label
(click image for full-size original)

Salicylic Acid Lotion, 6% Front Label

Salicylic Acid Lotion, 6% Back Label

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL

Salicylic Acid Cream, 6%

Rx Only

Salicylic Acid Cream, 6% Front Label Image
(click image for full-size original)

Salicylic Acid Cream, 6% Front Label Image

Salicylic Acid Cream, 6% Back Label Image
(click image for full-size original)

Salicylic Acid Cream, 6% Front Label Image

Salicylic Acid Cream, 6% Back Label Image

SALICYLIC ACID
salicylic acid lotion
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:45802-818
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SALICYLIC ACID (SALICYLIC ACID) SALICYLIC ACID 6 mg in 100 mL
Inactive Ingredients
Ingredient Name Strength
AMMONIUM LACTATE
BEHENTRIMONIUM CHLORIDE
ISOPROPYL ALCOHOL
CETYL ALCOHOL
DIMETHICONE 350
EDETATE DISODIUM
GLYCERIN
GLYCERYL MONOSTEARATE
METHYLPARABEN
MINERAL OIL
PEG-100 STEARATE
PROPYLPARABEN
WATER
STEARYL ALCOHOL
TROLAMINE
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:45802-818-41 414 mL in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
Unapproved drug other 09/27/2007 01/01/2019
SALICYLIC ACID
salicylic acid cream
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:45802-806
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
AMMONIUM LACTATE
BEHENTRIMONIUM CHLORIDE
ISOPROPYL ALCOHOL
CETYL ALCOHOL
DIMETHICONE 350
EDETATE DISODIUM
GLYCERIN
GLYCERYL STEARATE SE
METHYLPARABEN
MINERAL OIL
PEG-100 STEARATE
PHENOXYETHANOL
PROPYLPARABEN
WATER
STEARYL ALCOHOL
TROLAMINE
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:45802-806-01 400 g in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
Unapproved drug other 09/07/2007 06/01/2018
Labeler — Perrigo New York Inc (078846912)

Revised: 09/2017 Perrigo New York Inc

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