Label: RELOVOX- renewing clarifying cleanser emulsion

  • 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 March 31, 2011

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  • ACTIVE INGREDIENT

    Active Ingredient; Benzoyl Peroxide 2.5% (w/w)
  • DOSAGE & ADMINISTRATION

    Apply on the skin with a gentle massage twice a day, rinse thoroughly with hot water, pat dry with a clean towel. Children under 2 years of age, consult your doctor

    Use for the management of acne and pimples and acne spots removal.

    Indicated and use for the management of acne and removal of the acne spots, Apply on the skin with a gentle massage twice a day, rinse thoroughly with hot water, pat dry with a clean towel.Children under 2 years of age, consult your doctor

    Keep out of reach of children, store in a cool dry place at room temperature.

    Inactive Ingredients; water, Isoprpopyl Alcohol, glycerin, ethyl alcohol, staeric acid, carbomer, sodium hydroxide, cocamidopropyl betain, sodium lauryl sulfate, castor oil,glycolic acid, salicylic acid, cocoa butter, vitamin E, vitamin A,  grape seeds oil.
  • DO NOT USE

    •    Ask your doctor if you using other acne medications
    •    Do not use if you are allergic to Benzoyl Peroxide
    •    Do not use in or near the eyes
    •    Do not use in large amount particularly over the raw surfaces or blisters
    Stop use and Ask Doctors if
    •    Allergic reactions occurs
    •    Condition worsen and does not improve
    •    Excessive dryness and peeling of skin occurs
    •    itching, redness, burning , swelling or other symptoms occurs
    •    Keep both used and unused medicine out of the reach of children or pets
    •    If swallowed get medical attention right away Call your doctor immediately.

    •    Do not use in or near the eyes
    •    Do not use in large amount particularly over the raw surfaces or blisters
    Stop use and Ask Doctors if
    •    Allergic reactions occurs
    •    Condition worsen and does not improve
  • PRINCIPAL DISPLAY PANEL

    carton.jpg
    image of carton label
  • INGREDIENTS AND APPEARANCE
    RELOVOX 
    renewing clarifying cleanser emulsion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51350-005
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZOYL PEROXIDE (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM) BENZOYL PEROXIDE25 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    CARBOMER HOMOPOLYMER TYPE C (UNII: 4Q93RCW27E)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    ZINC ACETATE (UNII: FM5526K07A)  
    ALCOHOL (UNII: 3K9958V90M)  
    ALOE (UNII: V5VD430YW9)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    GLYCOLIC ACID (UNII: 0WT12SX38S)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    CASTOR OIL (UNII: D5340Y2I9G)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    SALICYL ALCOHOL (UNII: FA1N0842KB)  
    SALICYLIC ACID (UNII: O414PZ4LPZ)  
    VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51350-005-061 in 1 CARTON
    1NDC:51350-005-0530 g in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333D03/31/2011
    Labeler - Transdermal Corp (963383612)
    Registrant - Transdermal Corp (963383612)
    Establishment
    NameAddressID/FEIBusiness Operations
    Transdermal Corp963383612manufacture, label, analysis, pack
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