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.

SA 6% 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 SA 6% , 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 accidental contamination of the child.

Carcinogenesis, Mutagenesis, Impairment of Fertility: No data are available concerning potential carcinogenic or reproductive effects of SA 6%. It has been shown to lack mutagenic potential in the Ames test.

ADVERSE REACTIONS

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

Call your physician for medical advice about side effects.

OVERDOSAGE See Warnings.

DOSAGE AND ADMINISTRATION

The preferable method of use is to apply SA 6% 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 a 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 SA 6% 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 SA 6% will not necessarily increase its therapeutic benefit, but could result in increased local intolerance and systemic adverse effects such as salicylism.

HOW SUPPLIED:

SA 6% Cream is available in 14 oz (400 g) bottles, NDC 42808-0302-14.

SA 6% Lotion is available in 14 oz (400 g) bottles, NDC 42808-0301-14.

Store at 25°C (77°F); excursions permitted to 15°-30° C (59°-86°F). See USP Controlled Room Temperature. Protect from freezing.

Manufactured in the U.S.A. for Exact-Rx, Inc., Melville, NY 11747

00-0301-14-205-00/00-302-14-205-00

Iss:5/11

PRINCIPAL DISPLAY PANEL — SA 6% Lotion

For External Use Only

NDC 42808-0301-14 Rx Only

Salicylic Acid

6%

LOTION

Exact-Rx. INCORPORATED

Net Wt. 14 oz (400 g)

00-301-14-200-00

SA 6% Lotion
(click image for full-size original)
SALICYLIC ACID
salicylic acid lotion
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:42808-301
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SALICYLIC ACID (SALICYLIC ACID) SALICYLIC ACID 60 mg in 1 g
Inactive Ingredients
Ingredient Name Strength
TROLAMINE
WATER
METHYLPARABEN
PROPYLPARABEN
PEG-100 STEARATE
CETYL ALCOHOL
MINERAL OIL
GLYCERYL 1-STEARATE
DIMETHICONE 350
AMMONIUM LACTATE
EDETATE DISODIUM
GLYCERIN
CETOSTEARYL ALCOHOL
POLYSORBATE 60
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:42808-301-14 400 g in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
UNAPPROVED DRUG OTHER 08/01/2011
Labeler — Exact-Rx, Inc. (137953498)

Revised: 08/2011 Exact-Rx, Inc.

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