Label: ACNE FORTE ACNE TREATMENT CREAM- benzoyl peroxide cream

  • NDC Code(s): 52063-709-00
  • Packager: GSCM Ventures Inc. DBA Revitol
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated November 10, 2023

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  • Drug Facts

  • Active ingredients

    Benzoyl peroxide 5.00%

    Purpose

    Acne Treatment

  • Uses:

    • For the treatment of acne.
  • Warnings:

    For external use only

    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 wih 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. 

    Do not use if you

    • have very sensitive skin 
    • are sensitive to benzoyl peroxide.

    Stop use and ask a doctor if

    irritation becomes severe.

    Keep out of reach of children.

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

    If pregnant or breast-feeding, 

    ask a health professional before use

  • 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
  • Other information:

    • Protect the product in this container from excessive heat and direct sun.
  • Inactive ingredients:

    Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Allantoin, ALoe Barbadensis Leaf (Aloe Vera Gel) Juice, Aqua (Deionized Water), Benzyl Alcohol, Betula Alba (Brich) Extract, Camellia Sinensis (Green Tea) Extract, camellia Sinensis (White Tea) Extract, Citrus Aurantium Dulcis (Orange) Oil, Citrus Medica Limonum (Lemon) Oil, DMDM Hydantoin, Glycerin, Hamamelis Virginiana (Witch Hazel), Iodopropynyl Butylcarbamate, Manuka Honey, Methylisothiazolinone, Parfum (Fragrance), Propylene Glycol, Melaleuca Alternifolia (Tea Tree) Oil, Polysorbate-20, Salix Nigra (Willow) Bark Extract, Saccharum Officinarum (Sugar Cane) Extract, Salvia Officinalis (Sage) Extract, Sodium Citrate, Sodium Hyaluronate, Triethanolamine, Vaccinium Myrtillus (Bilberry Extract, Xanthan Gum.

  • Questions?

    +40 (744) 569 069

  • Package Labeling:

    Label

  • INGREDIENTS AND APPEARANCE
    ACNE FORTE ACNE TREATMENT CREAM 
    benzoyl peroxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52063-709
    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
    CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)  
    ALLANTOIN (UNII: 344S277G0Z)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    WATER (UNII: 059QF0KO0R)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    WHITE TEA (UNII: O0M3396E09)  
    ORANGE OIL, COLD PRESSED (UNII: AKN3KSD11B)  
    LEMON (UNII: 24RS0A988O)  
    DMDM HYDANTOIN (UNII: BYR0546TOW)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK (UNII: T7S323PKJS)  
    IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)  
    METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    SALIX NIGRA BARK (UNII: QU52J3A5B3)  
    SUGARCANE (UNII: 81H2R5AOH3)  
    SAGE (UNII: 065C5D077J)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    BILBERRY (UNII: 9P2U39H18W)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:52063-709-001 in 1 BOX01/10/2022
    159 mL in 1 JAR; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00601/10/2022
    Labeler - GSCM Ventures Inc. DBA Revitol (184784283)
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