Label: ACNEFREE DERMATOLOGY INSPIRED CARE OIL FREE ACNE CLEANSER- benzoyl peroxide liquid
- NDC Code(s): 49967-308-01, 49967-308-02
- Packager: L'Oreal USA Products 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 July 3, 2018
If you are a consumer or patient please visit this version.
- Drug Facts
- Active ingredient
- Do not use if you
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 the product less frequently or in a lower concentration.
- Stop use and ask a doctor if
- Keep out of reach of children.
- use every morning and evening
- apply a dime-size amount to damp skin and gently massage, avoiding the eye area
- rinse well
- use wash on entire affected area one to two times daily
- because excessive drying of the skin may occur, start with washing once daily, then gradually increase to two times daily if needed or as directed by a doctor
- if bothersome dryness or peeling occurs, reduce cleansing 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.
- may be used on chest or back
water, glycerin, propylene glycol, cocamidopropyl hydroxysultaine, sodium C14-16 olefin sulfonate, xanthan gum, citric acid, potassium hydroxide, methyl methacrylate/glycol dimethacrylate crosspolymer, sodium lauroyl lactylate, glycolic acid, ceramide NP, ceramide AP, phytosphingosine, cholesterol, carbomer, ceramide EOP
- Questions or comments?
- PRINCIPAL DISPLAY PANEL
INGREDIENTS AND APPEARANCE
ACNEFREE DERMATOLOGY INSPIRED CARE OIL FREE ACNE CLEANSER
benzoyl peroxide liquid
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:49967-308 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 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) GLYCERIN (UNII: PDC6A3C0OX) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) COCAMIDOPROPYL HYDROXYSULTAINE (UNII: 62V75NI93W) SODIUM C14-16 OLEFIN SULFONATE (UNII: O9W3D3YF5U) XANTHAN GUM (UNII: TTV12P4NEE) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) POTASSIUM HYDROXIDE (UNII: WZH3C48M4T) METHYL METHACRYLATE/GLYCOL DIMETHACRYLATE CROSSPOLYMER (UNII: EG97988M5Q) SODIUM LAUROYL LACTYLATE (UNII: 7243K85WFO) GLYCOLIC ACID (UNII: 0WT12SX38S) CERAMIDE 3 (UNII: 4370DF050B) CERAMIDE 6 II (UNII: F1X8L2B00J) PHYTOSPHINGOSINE (UNII: GIN46U9Q2Q) CHOLESTEROL (UNII: 97C5T2UQ7J) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49967-308-01 237 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 08/10/2017 2 NDC:49967-308-02 59 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 08/10/2017 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part333D 08/10/2017 Labeler - L'Oreal USA Products Inc (002136794) Establishment Name Address ID/FEI Business Operations Universal Packaging Systems, Inc. 790530976 MANUFACTURE(49967-308)