Label: SUPER BUMP RELIEF- benzoyl peroxide and salicylic acid 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 June 6, 2011

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  • Active ingredient

    Benzoyl Peroxide 4%

    Salicylic Acid 3%

  • Purpose

    Elimination of razor bumps and prevention of ingrown hairs

  • Uses

    Elimination of razor bumps and prevention of ingrown hairs

  • Warnings

    Avoid contact with eyes or fabric.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.

  • Directions

    After shaving with a razor or clippers, apply SBR on the entire shaved area, exfoliate with finger tips for 5 minutes, then rinse well or remove with a white wet cloth. In case of severe out-break of folliculitis, apply SBR, exfoliate and leave on overnight and remove with white wet cloth in the morning.

  • Inactive ingredients

    Water (Aqua), Glycerin, Alcohol Denat, Propylene Glycol, Magnesium Sulfate Hepta-hydrate, Triethanolamine, Aloe Barbadensis Leaf Extract, Methylparaben, Hamamelis Virginiana (Witch Hazel) Extract, Cinnamomum Camphora (Camphor) Oil, Xanthan Gum, Carbomer, Titanium Dioxide, Magnesium Aluminum Silicate, Imidazolidinyl Urea.

  • Package/Label Principal Display Panel - Bottle Label

     

    Package/Label Principal Display Panel - Bottle Label

    Bottle Label

    Super Bump Relief

    Developed for

    The Elimination of Razor Bumps

    and

    The Prevention of Ingrown Hairs

    Doctor Recommended

    Net Wt. 4 oz. (112.9 gr.)

    Manufactured: Elements Inc.

    N.D.C. 65840

    Maxamillion's Gentlemen's Quarters

    Barber Parlor

  • INGREDIENTS AND APPEARANCE
    SUPER BUMP RELIEF 
    benzoyl peroxide and salicylic acid cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65840-100
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZOYL PEROXIDE (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM) BENZOYL PEROXIDE4 g  in 100 g
    SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID3 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ALCOHOL (UNII: 3K9958V90M)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    MAGNESIUM SULFATE HEPTAHYDRATE (UNII: SK47B8698T)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    CAMPHOR OIL (UNII: 75IZZ8Y727)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)  
    IMIDUREA (UNII: M629807ATL)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:65840-100-01113 g in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333D06/08/2011
    Labeler - Elements Personal Care, Inc. (018721058)
    Establishment
    NameAddressID/FEIBusiness Operations
    Fragrance Manufacturing, Inc.793406000MANUFACTURE
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