Label: BABYSPA SHEA BUTTER DIAPER- zinc oxide cream

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

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Drug Label Information

Updated July 18, 2012

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  • ACTIVE INGREDIENT

    Drug Facts
    Active Ingredients            Purpose
    Zinc Oxide 12%......................Skin Protectant

  • PURPOSE

    Uses:

        * Helps treat and prevent diaper rash and other minor skin irritations
        * Seals out wetness
  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children
    If swallowed, get medical help or contact a Poison Control Center right away
    (U.S. -- 1-800-222-1222)
  • INDICATIONS & USAGE

    Directions:
    Apply cream liberally, as often as necessary, with each diaper change for continuous protection
  • WARNINGS

    Warnings:
    For external use only
  • DOSAGE & ADMINISTRATION

    Stop use and ask a doctor if:

        * condition worsens
        * symptoms last more than 7 days

  • INACTIVE INGREDIENT

    shea butter (butyrospermum parkii), aloe barbadensis gel, cocoa (theobroma cacao) butter, beeswax, potato (solanium tuberosum) starch, cetearyl alcohol, grape (vitis vinifera) seed oil, kaolin, sesame (sesamum indicum) oil, titanium dioxide, phenoxyethanol, licorice (glycyrrhiza glabra) root extract, calendula officinalis seed oil, Unisooth EG-28 (water  propyl gallate  gallyl glucoside  epigallocatechin gallatyl glucoside), glyceryl caprylate, olive (olea europaea) oil*, glycerin, chamomile (anthemis nobilis ) extract, benzoic acid, dehydroacetic acid, borage (borago officinalis) seed oil, evening primrose (oenothera biennis) oil, fragrance, lavender (lavandula angustifolia) extract.
  • PRINCIPAL DISPLAY PANEL

    label image
  • INGREDIENTS AND APPEARANCE
    BABYSPA  SHEA BUTTER DIAPER
    zinc oxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:42957-001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide120 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    SHEA BUTTER (UNII: K49155WL9Y)  
    ALOE VERA FLOWER (UNII: 575DY8C1ER)  
    COCOA BUTTER (UNII: 512OYT1CRR)  
    YELLOW WAX (UNII: 2ZA36H0S2V)  
    STARCH, POTATO (UNII: 8I089SAH3T)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    GRAPE SEED OIL (UNII: 930MLC8XGG)  
    KAOLIN (UNII: 24H4NWX5CO)  
    SESAME OIL (UNII: QX10HYY4QV)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    GLYCYRRHIZA GLABRA (UNII: 2788Z9758H)  
    CALENDULA OFFICINALIS SEED OIL (UNII: 9JS8DS42SV)  
    WATER (UNII: 059QF0KO0R)  
    PROPYL GALLATE (UNII: 8D4SNN7V92)  
    LAURYL GLUCOSIDE (UNII: 76LN7P7UCU)  
    EPIGALLOCATECHIN GALLATE (UNII: BQM438CTEL)  
    GLYCERYL CAPRYLATE (UNII: TM2TZD4G4A)  
    OLIVE OIL (UNII: 6UYK2W1W1E)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    CHAMAEMELUM NOBILE FLOWER (UNII: O2T154T6OG)  
    BENZOIC ACID (UNII: 8SKN0B0MIM)  
    DEHYDROACETIC ACID (UNII: 2KAG279R6R)  
    BORAGE OIL (UNII: F8XAG1755S)  
    OENOTHERA BIENNIS (UNII: 76UI55V071)  
    LAVANDULA ANGUSTIFOLIA FLOWER (UNII: 19AH1RAF4M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:42957-001-01100 mL in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other07/18/2012
    Labeler - EXPRO3 LLC (014904067)
    Registrant - E.L. Erman Cosmetic Manufacturing Ltd (531894152)
    Establishment
    NameAddressID/FEIBusiness Operations
    E.L. Erman Cosmetic Manufacturing Ltd531894152manufacture(42957-001)
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