Label: ACNE TREATMENT- benzoyl peroxide lotion

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated October 27, 2023

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

  • SkinTx Acne Treatment Lotion Benzoyl Peroxide Lotion USP 5%

  • Active Ingredient

    Benzoyl Peroxide 5%

  • Purpose

    Acne Treatment

  • Use

    For the treatment of acne. Dries, clears and helps keep skin clear of new acne pimples, blackheads and whiteheads.

  • Warnings

    For external use only

  • Ask a doctor before use if you are

    • using other topical acne medications at the same time or immediately following use of this product may increase dryness or irritation of the skin.  If this occurs, only one medication should be used unless directed by a doctor.
  • Keep out of reach of children.

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

  • Do not use if you

    • have very sensitive skin.
    • are sensitive to Benzoyl Peroxide.
  • When using this product

    • avoid unnecessary sun exposure and use a sunscreen
    • avoid contact with 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 oncentration.
  • Stop use and ask a doctor if

    • irritation becomes severe.
  • Directions

    • Wash hands with a non-medicated soap (contains no Benzoyl Peroxide).
    • Cleanse and dry face thoroughly 5 minutes before use.
    • Using fingertips apply evenly to affected areas.
    • Use both morning and night or as directed by a physician.
    • If dryness or peeling occurs, reduce application to once a day or every other day.
    • Fair- skinned individuals should begin with one application.
    • For more severe cases, and/or if substantial improvement is not apparent within 3 to 4 weeks, consult a health care practitioner.
  • Inactive Ingredients

    C13-14 Isoparaffin, Ethylhexylglycerin, Lanolin Oil, Laureth-4, Laureth-7, Magnesium Aluminum Silicate, Phenoxyethanol, Polyacrylamide, Propylene Glycol, Water/Eau, Xanthan Gum.

  • Other Information

    •  store at room temperature (59-86°F / 15-30°C)
  • SkinTx Acne Treatment Lotion Benzoyl Peroxide Lotion USP 5%

    12

  • INGREDIENTS AND APPEARANCE
    ACNE TREATMENT 
    benzoyl peroxide lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67226-2050
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZOYL PEROXIDE (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM) BENZOYL PEROXIDE50 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    C13-14 ISOPARAFFIN (UNII: E4F12ROE70)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    LANOLIN OIL (UNII: OVV5IIJ58F)  
    LAURETH-4 (UNII: 6HQ855798J)  
    LAURETH-7 (UNII: Z95S6G8201)  
    MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:67226-2050-31 in 1 BOX11/01/2011
    130 mL in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00611/01/2011
    Labeler - Vivier Pharma, Inc. (250996550)
    Establishment
    NameAddressID/FEIBusiness Operations
    Dermolab Pharma Ltd245414743manufacture(67226-2050)