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.
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.
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.
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
PRINCIPAL DISPLAY PANEL — SA 6% Lotion
For External Use Only
NDC 42808-0301-14 Rx Only
Net Wt. 14 oz (400 g)
| SALICYLIC ACID |
salicylic acid lotion
|Labeler — Exact-Rx, Inc. (137953498)|
Revised: 08/2011 Exact-Rx, Inc.
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