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BabySpa (EXPRO3 LLC)

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CREAM 100 mL in 1 TUBE (42957-001-01) Label Information

Complete BabySpa Information

  • 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.
  • INGREDIENTS AND APPEARANCE
    BABYSPA  SHEA BUTTER DIAPER
    zinc oxide cream
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:42957-001
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide 120 mg  in 1 mL
    Inactive Ingredients
    Ingredient Name Strength
    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 Code Package Description Marketing Start Date Marketing End Date
    1 NDC:42957-001-01 100 mL in 1 TUBE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    unapproved drug other 07/18/2012
    Labeler - EXPRO3 LLC (014904067)
    Registrant - E.L. Erman Cosmetic Manufacturing Ltd (531894152)
    Establishment
    Name Address ID/FEI Business Operations
    E.L. Erman Cosmetic Manufacturing Ltd 531894152 manufacture(42957-001)