Label: NEUTROGENA STUBBORN ACNE AM TREATMENT- benzoyl peroxide gel
- NDC Code(s): 69968-0653-1, 69968-0653-2
- Packager: Johnson & Johnson Consumer Inc.
- 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 January 6, 2023
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active ingredient
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. If contact occurs, flush thoroughly with water
- avoid contact with hair or dyed products, 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 the product less frequently or in a lower concentration.
- 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
- Inactive ingredients
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 56 g Tube Carton
INGREDIENTS AND APPEARANCE
NEUTROGENA STUBBORN ACNE AM TREATMENT
benzoyl peroxide gel
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69968-0653 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BENZOYL PEROXIDE (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM) BENZOYL PEROXIDE 25 mg in 1 g Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL OR ALLYL SUCROSE CROSSLINKED) (UNII: K6MOM3T5YL) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) SODIUM HYDROXIDE (UNII: 55X04QC32I) CHLORPHENESIN (UNII: I670DAL4SZ) EDETATE DISODIUM (UNII: 7FLD91C86K) LAURETH-4 (UNII: 6HQ855798J) HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69968-0653-2 1 in 1 CARTON 08/03/2020 1 56 g in 1 TUBE; Type 0: Not a Combination Product 2 NDC:69968-0653-1 12 in 1 PACKAGE 08/03/2020 2 9 g in 1 TUBE; 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 08/03/2020 Labeler - Johnson & Johnson Consumer Inc. (118772437)