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

  • NDC Code(s): 49967-044-04
  • 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.

  • Severe Acne 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 chidren.

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

  • 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 orcomments

    1-888-768-2913

  • Severe Acne 24 HR 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 denatured, 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 cid, chamomilla recutita flower extract/matricaria flower extract, pantolactone

  • Questions orcomments?

    1-888-768-2913

  • Severe Acne 24 HR Acne Clearing System Retinol Night Cream

    Warnings: Avoid direct contact with eyes and lips. If contact occurs, rinse thoroughly with water.

    Always apply a broad-spectrum sunscreen while using retinol products and for 1 week after stopping use.

  • Directions

    If you have never used retinol products, begin use two evenings a week, then gradually increase frequency to every other night, and finally once an evening as tolerated. Do not use in association with other products containing retinol.

  • Ingredients

    water, mineral oil, cetearyl alcohol, glycerin, dimethicone, glyceryl stearate, PEG-100 stearate, polysorbate 60, caprylic/capric triglyceride, cetyl alcohol, bisabolol, retinol, sodium hyaluronate, xanthan gum, polysorbate 20, allantoin, C12-15 alkyl benzoate, cetyl palmitate, farnesol, neopentyl glycol dicaprylate/dicaprate, tridecyl stearate, ceramide 3, cetyl triethylmonium dimethiocone PEG 8 succinate, glycine soja (soybean) sterols, tridecyl trimellitater, triethanolamine, disodium EDTA, butylparaben, ethylparaben, propylparaben, isobutylparaben, methylparaben, phenoxyethanol, methylisothiazolinone

  • Questions or comments?

    1-888-768-2913

  • Severe Acne 24 HR Acne Clearing System MAXIMUM STRENGTH ACNE LOTION

    Drug Facts

  • Active ingredient

    Benzoyl Peroxide 10%

  • 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

    • 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, butylene glycol, C12-15 alkyl benzoate, glycerin, glyceryl stearate, PEG-100 stearate, cetearyl alcohol, phenoxyethanol, hydroxypropyl starch phosphate, polysorbate 60, dimethicone, xanthan gum, cetyl alcohol, bisabolol, tetrasodium EDTA, ethylhexylglycerin, methylisothiazolinone, benzalkonium chloride, sea whip extract, zingiber officinale (ginger) root extract, chamomilla recutita (matricaria) flower extract, alcohol, leuconostoc/radish root ferment filtrate, methylparaben, disodium EDTA, ethylparaben, methyl methacrylate/glycol dimethacrylate crosspolymer

  • Questions or comments?

    1-888-768-2913

  • 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 SEVERE ACNE 24 HR ACNE CLEARING SYSTEM 
    benzoyl peroxide kit
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49967-044
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49967-044-041 in 1 CARTON; Type 0: Not a Combination Product08/16/2017
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 11 BOTTLE 118 mL
    Part 21 BOTTLE 59 mL
    Part 1 of 2
    ACNEFREE SEVERE OIL FREE ACNE CLEANSER 
    benzoyl peroxide cream
    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)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    CERAMIDE 3 (UNII: 4370DF050B)  
    CERAMIDE 6 II (UNII: F1X8L2B00J)  
    PHYTOSPHINGOSINE (UNII: GIN46U9Q2Q)  
    CHOLESTEROL (UNII: 97C5T2UQ7J)  
    CERAMIDE 1 (UNII: 5THT33P7X7)  
    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 finalpart333D08/16/2017
    Part 2 of 2
    ACNEFREE MAXIMUM STRENGTH 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 PEROXIDE100 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    POLYSORBATE 60 (UNII: CAL22UVI4M)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    LEVOMENOL (UNII: 24WE03BX2T)  
    EDETATE SODIUM (UNII: MP1J8420LU)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
    PSEUDOPTEROGORGIA ELISABETHAE (UNII: UDY3H1OUX5)  
    GINGER (UNII: C5529G5JPQ)  
    CHAMOMILE (UNII: FGL3685T2X)  
    ALCOHOL (UNII: 3K9958V90M)  
    LEUCONOSTOC/RADISH ROOT FERMENT FILTRATE (UNII: D2QHA03458)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    ETHYLPARABEN (UNII: 14255EXE39)  
    METHYL METHACRYLATE/GLYCOL DIMETHACRYLATE CROSSPOLYMER (UNII: EG97988M5Q)  
    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 finalpart333D08/16/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333D08/16/2017
    Labeler - L'Oreal USA Products Inc (002136794)
    Establishment
    NameAddressID/FEIBusiness Operations
    Universal Packaging Systems, Inc.790530976MANUFACTURE(49967-044)