For Dermatologic use: Salicylic Acid 6% w/w Shampoo is indicated for removal of excessive keratin in hyperkeratotic skin disorders where the skin becomes thicker than usual.
Important Safety Information
- For external use only. Avoid contact with eyes and other mucous membranes.
- Do not use Salicylic Acid 6% (w/w) Shampoo if you are sensitive to salicylic acid or any other listed ingredients.
- Do not use Salicylic Acid 6% (w/w) Shampoo in children under 2 years of age.
- Prolonged use over large areas, especially in children and patients with significant renal or hepatic impairment could result in salicylism.
- Excessive application beyond what is needed to cover the affected area will not produce better results.
- In children under 12 years of age and patients with renal or hepatic impairment, limit application to the affected area and monitor for signs of salicylate toxicity: nausea, vomiting, dizziness, loss of hearing, tinnitus, lethargy, hyperpnea, diarrhea, and psychic disturbances.
- In the event of salicylic acid toxicity, discontinue use.
- There are no adequate and well-controlled studies in pregnant women.
- No data is available concerning potential carcinogenic or reproductive effects of Salicylic Acid 6% (w/w) Shampoo.
- Side effects such as excessive erythema and scaling could result from use on open skin lesions.
- Drug interactions can occur. Please see Full Prescribing Information for a complete list.
For additional safety and other information, including Patient Information, please see Full Prescribing Information. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.