Label: BABYSPA CALMING RELIEF ECZEMA- colloidal oatmeal cream

  • Category: HUMAN OTC DRUG LABEL

DISCLAIMER: Most OTC drugs are not reviewed and approved by 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 March 7, 2013

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

View All Sections
  • 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

  • PRINCIPAL DISPLAY PANEL

    box label

  • INGREDIENTS AND APPEARANCE
    BABYSPA CALMING RELIEF ECZEMA 
    colloidal oatmeal cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:42957-002
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OATMEAL (UNII: 8PI54V663Y) (OATMEAL - UNII:8PI54V663Y) OATMEAL1.25 g  in 125 g
    Inactive Ingredients
    Ingredient NameStrength
    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 CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:42957-002-021 in 1 BOX
    1NDC:42957-002-01125 g in 1 TUBE
    2NDC:42957-002-034 g in 1 POUCH
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34703/25/2013
    Labeler - Expro3, LLC (014904067)
    Establishment
    NameAddressID/FEIBusiness Operations
    EL Erman Manufacturing, Ltd.531894152manufacture(42957-002)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials

More Info on this Drug

Get Label RSS Feed, View NDC Code(s)NEW!