The following Structured Product Label (SPL) was submitted to the FDA by Md Formulation for the product Glycare Acne (NDC 66078-035). 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 otc - active ingredient, otc - purpose, otc - keep out of reach of children, indications & usage, warnings, dosage & administration, inactive ingredient, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Otc - Active Ingredient
Salicylic Acid 1%
Otc - Purpose
Acne Tratment
Otc - Keep Out Of Reach Of Children
If swallowed, get medical help or contact a Poison Control Center right away.
Indications & Usage
Clears up acne blemishes and helps prevent new acne blemishes.
Warnings
For external use only.
Dosage & Administration
Directions Cleanse skin thoroughly before applying medication.Cover the entire affected area with a thin layer 1 to 3 times dally. Because excessive drying of the skin may occur, start with 1 application daily, then gradually increase to 2 to 3 times daily if needed or as directed by a physician. If bothersome dryness or peeling occurs, reduce application to once a day or every other day.
Inactive Ingredient
Water (aqua), sd alcohol 40-b, glycolic acid, ammonium glycolate, hydroxypropyl melhylcellulose.
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