FDA Label for Acne

View Indications, Usage & Precautions

Acne Product Label

The following document was submitted to the FDA by the labeler of this product Greenbrier International Inc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Active Ingredient



Salicylic Acid 0.5%


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



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