Active Ingredient(S)
Benzoyl Peroxide 10%
Acne Treatment Cream
FDA Label NDC 51316-654
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Cvs Health for the product Acne Treatment Cream (NDC 51316-654). 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(s), purpose, use(s), for external use only, do not use, when using this product, stop use and ask a doctor if, pregnancy/breastfeeding, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Acne medication
Use(S)
for the treatment of acne
For External Use Only
For external use only
Do Not Use
• have very sensitive skin
•are sensitive to benzoyl peroxide
When Using This Product
When using this product • avoid unnecessary sun exposure and use a sunscreen • avoid contact with the eyes, lips, and mouth • avoid contact with hair and dyed fabrics, which may be bleached by this product •skin irritation and dryness is more likely to occur if you use another topical acne medication at the same time. If irritation occurs, only use one topical acne medication at a time • skin irritation may occur, characterized by redness, burning, itching, peeling or possibly swelling. Irritation may be reduced by using the product less frequently or in a lower concentration.
Stop Use And Ask A Doctor If
if irritation becomes severe
Pregnancy/Breastfeeding
If pregnant or breastfeeding, ask a health professional before use
Keep Out Of Reach Of Children
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) immediately
Directions
Directions • clean the skin thoroughly before applying this product • cover the entire affected area with a thin layer one to three times daily • 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 or every other day • if going outside,apply sunscreen after using this product. If irritation or sensitivity develops, stop use of both products and ask a doctor.
Other Information
• keep tightly closed •store at room temperature.
Inactive Ingredients
bentonite, carbomer, ethylhexylglycerin, glyceryl stearate, isopropyl myristate, PEG-12 dimethicone, phenoxyethanol, propylene glycol, sodium hydroxide, water.
Questions
Questions or comments?
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Compare to clearasil 5 in 1 Acne Spot Treatment Cream*
Daily Acne Treatment Cream
MAXIMUM STRENGTH ACNE TREATMENT
• 10% Benzoyl peroxide acne medication
• Helps clear existing acne pimples & prevent new ones from forming
•Dermatologist tested
PARABEN
Acne Treatment Cream (Acne Treatment Cream 1)
FREE
PHTHALATE
NET WT 1 OZ (28 g)
* Please review the disclaimer below.
