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 6% (w/w) Shampoo should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Because of the potential for serious adverse reactions in nursing infants from the mother’s use of Salicylic Acid 6% (w/w) Shampoo, 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 is available concerning potential carcinogenic or reproductive effects of Salicylic Acid 6% (w/w) Shampoo. Salicylic acid has been shown to lack mutagenic potential in the Ames Salmonella test.
Adverse Reactions to Salicylic Acid 6 Percent
Excessive erythema and scaling conceivably could result from use on open skin lesions.
Wet hair and apply Salicylic Acid 6% (w/w) Shampoo to the scalp. Work into a lather then rinse. Repeat the treatment as needed until the condition clears. Once clearing is apparent, the occasional use of Salicylic Acid 6% (w/w) Shampoo will usually maintain the remission.
Salicylic Acid 6% (w/w) Shampoo is available in 177mL plastic bottles (NDC 42546-279-06).
Store at controlled room temperature 20°-25°C (68°-77°F). Do not freeze.
18899 N Thompson Peak Pkwy
Scottsdale, AZ 85255
FOR DERMATOLOGICAL USE ONLY
NOT FOR OPHTHALMIC, ORAL OR INTRAVAGINAL USE
| SALICYLIC ACID 6 PERCENT |
salicylic acid shampoo
|Labeler — PruGen, Inc. (929922750)|
|SUMMERS LABORATORIES, INC.||002382612||MANUFACTURE (42546-279)|
Revised: 12/2017 PruGen, Inc.
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