SUPER BUMP RELIEF (BENZOYL PEROXIDE AND SALICYLIC ACID) CREAM [ELEMENTS PERSONAL CARE, INC.]

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SUPER BUMP RELIEF (BENZOYL PEROXIDE AND SALICYLIC ACID) CREAM [ELEMENTS PERSONAL CARE, INC.]
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NDC 65840-100-01
Set ID 98963a9d-ade4-4254-ab78-64830dd0d15b
Category HUMAN OTC DRUG LABEL
Packager Elements Personal Care, Inc.
Generic Name
Product Class
Product Number
Application Number PART333D
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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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