Active Ingredient
Salicylic Acid 0.5%
Acne
FDA Label NDC 33992-1307
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Greenbrier International Inc for the product Acne (NDC 33992-1307). 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, purpose, uses, warnings, other, otc - stop use, otc - ask doctor/pharmacist, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Acne Treatment
Uses
for the treatment of acne
Warnings
Warnings
Other
For external use only.
Otc - Stop Use
Do not use if you have very sensitive skin or are sensitive to Salicylic Acid
Otc - Ask Doctor/Pharmacist
Ask a doctor or pharmacist before use if you are using other topical acne medications at the same time or immediately following use of this product. This may increase dryness or irritation of the skin. If this occurs, only one medication should be used unless directed by a doctor.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Directions
Cleanse the skin thoroughly before applying medication. Apply cream directly on acne pimples. Because excessive drying of the skin may occur, start with one application daily, then gradually increase to two or three times daily if needed or as directed by a doctor. If bothersome dryness or peeling occurs, reduce application to once a day.
Other Information
store at 20 to 25 C (66 to 77 F)
Inactive Ingredients
carbomer, cetyl alcohol, dimethicone, glycerin, glycol stearate, methylparaben, propylene glycol, propylparaben, squalane, triethanolamine, water
Package Label.Principal Display Panel
Acne Cream Label (Label)
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