Label: CLEAN AND CLEAR CONTINUOUS CONTROL ACNE CLEANSER- benzoyl peroxide cream
- NDC Code(s): 69968-0684-5
- 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.
Updated January 5, 2021
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- 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.
- Wet face. Gently massage all over face for 20 – 30 seconds, avoiding eye area. Rinse thoroughly and pat dry.
- Because excessive drying of the skin may occur, start with one application daily, then gradually increase to two 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 - 142 g Tube Label
INGREDIENTS AND APPEARANCE
CLEAN AND CLEAR CONTINUOUS CONTROL ACNE CLEANSER
benzoyl peroxide cream
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69968-0684 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BENZOYL PEROXIDE (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM) BENZOYL PEROXIDE 100 mg in 1 g Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) CETYL ALCOHOL (UNII: 936JST6JCN) PETROLATUM (UNII: 4T6H12BN9U) GLYCERIN (UNII: PDC6A3C0OX) STEARETH-2 (UNII: V56DFE46J5) ZINC LACTATE (UNII: 2GXR25858Y) POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT) CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO) XANTHAN GUM (UNII: TTV12P4NEE) BENZYL ALCOHOL (UNII: LKG8494WBH) LAURETH-4 (UNII: 6HQ855798J) EDETATE DISODIUM (UNII: 7FLD91C86K) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69968-0684-5 142 g in 1 TUBE; Type 0: Not a Combination Product 01/31/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part333D 01/31/2020 Labeler - Johnson & Johnson Consumer Inc. (002347102)