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BabySpa Calming Relief Eczema (Expro3, LLC)

Available Formats

Dosage Form Package Information Links
CREAM 4 g in 1 POUCH (42957-002-03) Label Information
CREAM 1 TUBE in 1 BOX (42957-002-02) > 125 g in 1 TUBE (42957-002-01) Label Information

Complete BabySpa Calming Relief Eczema Information

  • ACTIVE INGREDIENT

    Active Ingredient Purpose

    Colloidal Oatmeal 0.1%............Skin Protectant


  • PURPOSE

    Intensively Hydrates & Naturally Helps to Relieve Dry, Itchy, Irritated Skin due to Eczema & Rashes


  • KEEP OUT OF REACH OF CHILDREN

    Keep out of the reach of children


  • INDICATIONS & USAGE

    Uses:

    Temporarily protects and helps relieve minor skin irritation and itching due to:

    • eczema
    • rashes

  • WARNINGS

    For external use only

    When using this product:

    • do not get into eyes

    Stop use and ask a doctor if:

    • condition worsens
    • symptoms last more than 7 days or clear up and occur again within a few days

    If swallowed, get medical help or contact a Poison Control Center right away. (U.S. - 1-800-222-1222)


  • DOSAGE & ADMINISTRATION

    Directions:

    • Apply liberally to dry, itchy patches and irritated skin, as often as necessary.
    • Suitable for daily use.
    • Delicate enough to use on newborn skin.

    Other Information:

    For use on mild to moderate excema or as directed by a physician. Store at room temperature.


  • INACTIVE INGREDIENT

    Inactive Ingredients:

    water (aqua), vegetable glycerin, caprylic/capric/triglyceride, simmondsia chinensis (jojoba) seed oil*, butyrospermum parkii (shea butter), cetyl alcohol, aloe vera barbadensis leaf juice*, symphytum officinale leaf extract, phenoxyethanol, xanthan gum, caprylyl glycol, calendula officinalis flower oil, avena sativa (oat) kernel extract, bisabolol, anthemis nobilis (chamomile) flower extract*.

    *certified organic


  • INGREDIENTS AND APPEARANCE
    BABYSPA CALMING RELIEF ECZEMA 
    colloidal oatmeal cream
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:42957-002
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    OATMEAL (UNII: 8PI54V663Y) (OATMEAL - UNII:8PI54V663Y) OATMEAL 1.25 g  in 125 g
    Inactive Ingredients
    Ingredient Name Strength
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    JOJOBA OIL (UNII: 724GKU717M)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    COMFREY LEAF (UNII: DG4F8T839X)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)  
    LEVOMENOL (UNII: 24WE03BX2T)  
    CHAMAEMELUM NOBILE FLOWER (UNII: O2T154T6OG)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:42957-002-02 1 in 1 BOX
    1 NDC:42957-002-01 125 g in 1 TUBE
    2 NDC:42957-002-03 4 g in 1 POUCH
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part347 03/25/2013
    Labeler - Expro3, LLC (014904067)
    Establishment
    Name Address ID/FEI Business Operations
    EL Erman Manufacturing, Ltd. 531894152 manufacture(42957-002)