Label: ACNEFREE DERMATOLOGY INSPIRED CARE OIL FREE 24 HR ACNE CLEARING SYSTEM- benzoyl peroxide kit

  • NDC Code(s): 49967-716-03
  • 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.

Drug Label Information

Updated June 12, 2018

If you are a consumer or patient please visit this version.

  • Oil Free 24 HR Acne Clearing System ACNE LOTION

    Drug Facts

  • Active ingredient

    Benzoyl Peroxide 3.7%

  • 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.

  • Directons

    • 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.
  • Inactive ingredients

    water, propylene glycol, glycerin, carbomer, potassium hydroxide, polysorbate 80, methyl methacrylate/glycol dimethacrylate crosspolymer, disodium EDTA, sodium lauroyl lactylate, ceramide NP, ceramide AP, phytosphingosine, cholesterol, xanthan gum, ceramide EOP

  • Questions or comments?

    1-888-768-2913

  • Oil-Free 24 HR Acne Clearing System Oil Free Acne Cleanser

    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?

    1-888-768-2913

  • Oil Free 24 HR Acne Clearing System WITCH HAZEL MATTIFYING TONER

    Sunburn Alert: This product contains an alpha hydroxy acid (AHA) that may increase your skin’s sensitivity to the sun and particularly the possibility of sunburn. Use a sunscreen, wear protective clothing, and limit sun exposure while using this product and for a week afterwards.

    CAUTION: Flammable until dry.

    Keep away from flames and heat.

  • Directions

    Use every morning and evening to tone. After cleansing apply to entire face with a cotton pad, avoiding the eye area. Do not rinse. May also be used on chest and/or back.

  • Ingredients

    water, alcohol denat., hamamelis virginiana water/witch hazel water, hydrogenated starch hydrolysate, glycerin, polysorbate 20, glycolic acid, sodium hydroxide, citric acid, bisabolol, niacinamide, aloe barbadensis leaf juice powder, panthenol, propylene glycol, disodium EDTA, copper PCA, lactic acid, chamomilla recutita flower extract/matricaria flower extract, pantolactone

  • PRINCIPAL DISPLAY PANEL

    image of a carton

  • PRINCIPAL DISPLAY PANEL

    image of a carton

  • PRINCIPAL DISPLAY PANEL

    image of a label

  • PRINCIPAL DISPLAY PANEL

    image of a label

  • INGREDIENTS AND APPEARANCE
    ACNEFREE DERMATOLOGY INSPIRED CARE OIL FREE 24 HR ACNE CLEARING SYSTEM 
    benzoyl peroxide kit
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49967-716
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49967-716-031 in 1 CARTON; Type 0: Not a Combination Product08/18/2017
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 11 BOTTLE 59 mL
    Part 21 BOTTLE 118 mL
    Part 1 of 2
    OIL FREE 24 HOUR CLEARING SYSTEM OIL FREE ACNE 
    benzoyl peroxide lotion
    Product Information
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZOYL PEROXIDE (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM) BENZOYL PEROXIDE37 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    METHYL METHACRYLATE/GLYCOL DIMETHACRYLATE CROSSPOLYMER (UNII: EG97988M5Q)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    SODIUM LAUROYL LACTYLATE (UNII: 7243K85WFO)  
    CERAMIDE 3 (UNII: 4370DF050B)  
    CERAMIDE 6 II (UNII: F1X8L2B00J)  
    PHYTOSPHINGOSINE (UNII: GIN46U9Q2Q)  
    CHOLESTEROL (UNII: 97C5T2UQ7J)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    159 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333D08/18/2017
    Part 2 of 2
    OIL FREE 24 HOUR CLEARING SYSTEM OIL FREE ACNE CLEANSER 
    benzoyl peroxide liquid
    Product Information
    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
    1118 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333D08/18/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333D08/18/2017
    Labeler - L'Oreal USA Products Inc (002136794)
    Establishment
    NameAddressID/FEIBusiness Operations
    Universal Packaging Systems, Inc.790530976MANUFACTURE(49967-716)