Label: REVITOL ACNE TREATMENT- benzoyl peroxide cream

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not 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 April 14, 2011

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  • Active Ingredient..............................Purpose:

    Benzoyl Peroxide 5%..............................Acne Medication

  • Use:

    For the treatment of acne.

  • Warnings:

    For external use only.

  • Do not use

    if you have sensitive skin or are sensitive to benzoyl peroxide.

  • When using this product:

    • Avoid unnecessary sun exposure and use sunscreen.
    • Keep away from eyes, lips and mouth areas.
    • Using other topical acne drug at the same time or right after may increase dryness or irritation of skin. If this occurs, only one medication should be used unless directed by a doctor.
    • Irritation may develop, such as redness, burning, itching, peeling or possibly swelling.
    • It may bleach hair or dye fabrics.
  • Stop use and ask a doctor if

    irritation becomes severe and continues

  • Keep out of reach of children.

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

  • Directions:

    • Cleanse the skin thoroughly before applying  medication
    • Cover the entire affected area with a thin layer one to three times a day
    • Because excessive drying of the skin may occur, start with one application daily, then gradually increase to two ore three times daily if needed or as directed by a doctor. If bothersome drying or peeling occurs, reduce application to once a day or every other day.
    • If going outside, use a sunscreen. Allow Acne Treatment Cream to dry, then follow directions in sunscreen labeling if sensitivity develops, discontinue use of both products and ask a doctor.
  • Other Information:

    Enter section text here

  • Inactive Ingredients

    Water, Propylene Glycol, Carbomer  Allantoin, Triethanolamine, Sodium Hyaluronate, Melaleuca Alternafolia (Tea Tree) Leaf Oil, Betula Alba (Birch Sap) Juice, Epilobium Angustifolium (Willowherb) Flower/Leaf/Stem Extract, Vaccinium Myrtillus (Bilberry) Extract, Saccharum Officinarum (Sugar Cane) Extract, Citrus Aurantius Dulcis (Orange) Fruit Extract, Citrus Medica Limonum (Lemon) Peel, Salvia Officinalis (Sage) Leaf Extract, Hamamelis Virginiana (Witch Hazel) Extract, Honey Extract, Aloe Barbadensis Leaf Juice, Camellia Sinensis (Green Tea) Leaf Extract, Xathan Gum, DMDM Hydantoin, Benzyl Alcohol, Sodium Citrate, Sodium Hydroxide

  • Questions or Comments:

    1-800-756-4120 Mon - Fri 9AM to 5PM PST - Revitol Corp., 2049 North Lincoln Street, Burbank, CA 91504 - Made in the USA

  • PRINCIPAL DISPLAY PANEL

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    revitol_final_label

  • INGREDIENTS AND APPEARANCE
    REVITOL  ACNE TREATMENT
    benzoyl peroxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:24488-004
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZOYL PEROXIDE (UNII: W9WZN9A0GM) (BENZOIC ACID - UNII:8SKN0B0MIM) BENZOYL PEROXIDE2.95 mL  in 59 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    CARBOMER HOMOPOLYMER TYPE C (UNII: 4Q93RCW27E)  
    ALLANTOIN (UNII: 344S277G0Z)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    TEA TREE OIL (UNII: VIF565UC2G)  
    BETULA PUBESCENS RESIN (UNII: 9G931M6I4G)  
    EPILOBIUM ANGUSTIFOLIUM LEAF (UNII: 7NV86426N2)  
    BILBERRY (UNII: 9P2U39H18W)  
    SUGARCANE (UNII: 81H2R5AOH3)  
    ORANGE (UNII: 5EVU04N5QU)  
    LEMON PEEL (UNII: 72O054U628)  
    SAGE (UNII: 065C5D077J)  
    HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK (UNII: T7S323PKJS)  
    HONEY (UNII: Y9H1V576FH)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    DMDM HYDANTOIN (UNII: BYR0546TOW)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:24488-004-2059 mL in 1 JAR
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333D04/14/2011
    Labeler - Revitol Corporation (961956229)
    Registrant - Creation's Garden Natural Products (961956229)
    Establishment
    NameAddressID/FEIBusiness Operations
    Creation's Garden Natural Products961956229manufacture
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