Label: OXY ON-THE-GO ACNE STICK- benzoyl peroxide stick
- NDC Code(s): 10742-8304-1
- Packager: The Mentholatum Company
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated April 14, 2023
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- Active ingredient
- Purpose
- Uses
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Warnings
For external use only
When using 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.
- 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 may occur, characterized by redness, burning, itching, peeling, or possibly swelling. Irritation may be reduced by using this product less frequently or in a lower concentration.
- Keep Out of Reach of Children
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Directions
- clean skin thoroughly before applying this product
- cover entire affected area with a thin layer 1 to 3 times daily
- because excessive drying of the skin may occur, start with 1 application daily, then gradually increase to 2 or 3 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.
- Sensitivity Test: Apply product sparingly to a small affected area for the first 3 days. If no discomfort occurs, follow directions above.
- Storage and Handling
- Inactive Ingredients
- Questions
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INGREDIENTS AND APPEARANCE
OXY ON-THE-GO ACNE STICK
benzoyl peroxide stickProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:10742-8304 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BENZOYL PEROXIDE (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM) BENZOYL PEROXIDE 50 mg in 1 g Inactive Ingredients Ingredient Name Strength DIMETHICONE (UNII: 92RU3N3Y1O) METHYL METHACRYLATE (UNII: 196OC77688) MICROCRYSTALLINE WAX (UNII: XOF597Q3KY) SYNTHETIC WAX (1200 MW) (UNII: Q3Z4BCH099) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:10742-8304-1 1 in 1 PACKAGE 12/05/2016 1 2 g in 1 CYLINDER; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part333D 12/05/2016 Labeler - The Mentholatum Company (002105757)