Label: BABYSPA CALMING RELIEF ECZEMA- oatmeal cream 

  • Label RSS
  • NDC Code(s): 42957-002-01, 42957-002-02, 42957-002-03
  • Packager: Expro3, LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

NOTE: Most over the counter (OTC) are not reviewed and approved by the 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 03/13

If you are a consumer or patient please visit this version.

  • ACTIVE INGREDIENT

    Active Ingredient Purpose

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

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  • PURPOSE

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

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  • KEEP OUT OF REACH OF CHILDREN

    Keep out of the reach of children

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  • INDICATIONS & USAGE

    Uses:

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

    • eczema
    • rashes
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  • 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)

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  • 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.

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  • 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

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  • INGREDIENTS AND APPEARANCE
    BABYSPA CALMING RELIEF ECZEMA 
    colloidal oatmeal cream
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:42957-002
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    OATMEAL (OATMEAL) OATMEAL 1.25 g  in 125 g
    Inactive Ingredients
    Ingredient Name Strength
    WATER  
    GLYCERIN  
    MEDIUM-CHAIN TRIGLYCERIDES  
    JOJOBA OIL  
    SHEA BUTTER  
    CETYL ALCOHOL  
    ALOE VERA LEAF  
    COMFREY LEAF  
    PHENOXYETHANOL  
    XANTHAN GUM  
    CAPRYLYL GLYCOL  
    CALENDULA OFFICINALIS FLOWER  
    LEVOMENOL  
    CHAMAEMELUM NOBILE FLOWER  
    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)
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