Active Ingredient
Salicylic Acid 6%
Salicylic Acid 6% Gel
FDA Label NDC 71085-073
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Ipg Pharmaceuticals, Inc. for the product Salicylic Acid 6% Gel (NDC 71085-073). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredient, uses, directions, warning, other information, inactive ingredient, product label, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Uses
For the removal of excess keratin in hyperkeratotic disorders, including scaling associated with psoriasis or thickened skin of palms and soles, corns and calluses.
Directions
Apply Salicylic Acid 6% Gel thoroughly to the affected area and occlude the area at night. Preferably, the skin should be hydrated (soaked in water) for at least five minutes prior to application. The medication is washed off in the morning. In those areas where occlusion is difficult or impossible, application may be made more frequently. Once clearing is apparent, the occasional use of Salicylic Acid 6% Gel will usually
maintain the remission. Unless hands are being treated, hands should be rinsed thoroughly after application.
Warning
For external use only. Avoid contact with eyes and other mucous membranes. May cause mild irritation. If excessive irritation or sensitivity occurs, discontinue use and consult with your physician. Do not use on children under 2 years of age. Read package insert carefully. Flammable. Keep away from heat and open flame. Keep this and all medications out of reach of children.
Other Information
Store at controlled room temperature 59° to 86° F (15° to 30° C).
Inactive Ingredient
Hydroxypropyl Cellulose, Propylene Glycol
Product Label
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