ACNEFREE DERMATOLOGY INSPIRED CARE OIL FREE ACNE CLEANSER- benzoyl peroxide liquid 
L'Oreal USA Products Inc

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.

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Drug Facts

Drug Facts

Active ingredient

Benzoyl peroxide 2.5%

Purpose

Acne treatment

Use

for the treatment of acne

Warnings

For external use only

Do not use if you

  • have very sensitive skin
  • are sensitive to benzoyl peroxide

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

skin irritation becomes severe

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

  • 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

Inactive ingredients

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?

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ACNEFREE DERMATOLOGY INSPIRED CARE OIL FREE ACNE CLEANSER 
benzoyl peroxide liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49967-308
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZOYL PEROXIDE (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM) BENZOYL PEROXIDE25 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:49967-308-01237 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product08/10/201706/30/2021
2NDC:49967-308-0259 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product08/10/201706/30/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333D08/10/201706/30/2021
Labeler - L'Oreal USA Products Inc (002136794)
Establishment
NameAddressID/FEIBusiness Operations
Universal Packaging Systems, Inc.177711082MANUFACTURE(49967-308)

Revised: 7/2021
 
L'Oreal USA Products Inc