Label: BABY ECZEMA MOISTURIZING- colloidal oatmeal cream

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

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 September 12, 2014

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  • Active ingredient

    Colloidal Oatmeal 1%

  • Purpose

    Skin Protectant

  • 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.
  • Keep Out of Reach of Children.

    If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    •
    apply as needed
  • Inactive ingredients

    water, glycerin, distearyldimonium chloride, isopropyl palmitate, cetearyl alcohol, petrolatum, avena sativa (oat) kernel flour, dimethicone, steareth-21, panthenol (pro-vitamin B5), benzalkonium chloride, sodium chloride, ceramide 3, ceramide 6-II, ceramide 1, phytosphingosine, cholesterol, sodium lauroyl lactylate, carbomer, xanthan gum, sativa (oat) kernel oil, avena sativa (oat) kernel extract, triethanolamine.

  • Package/Label Principal Display Panel

    buybuy
    BABY™
    eczema
    MOISTURIZING
    CREAM

    colloidal oatmeal
    skin protectant

    Helps relieve dry, itchy
    and irritated skin

    Helps sooth eczema
    related skin conditions

    Steroid-free

    Fragrance-free

    DERMATOLOGIST
    TESTED

    NET WT 5 OZ (140 g)

    baby eczema
    moisturizing cream

    Enriched with soothing oatmeal, this innovative cream offers relief to help care
    for dry, itchy skin, while intensely moisturizing it. It helps to fortify your baby’s
    skin's natural barrier functions while helping to prevent the recurrence of dry
    skin. Our formula is enriched with ceramides, essential lipids naturally found in
    the skin, to enhance and restore the baby’s skin's natural protective function.

    MADE EXPRESSLY FOR
    buybuy BABY™
    650 Liberty Avenue,
    Union, NJ 07083
    © BUY BUY BABY INC.
    WWW.BUYBUYBABY.COM
    MADE IN ISRAEL

    Carton Label

    Container Label

  • INGREDIENTS AND APPEARANCE
    BABY ECZEMA MOISTURIZING 
    colloidal oatmeal cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63940-429
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OATMEAL (UNII: 8PI54V663Y) (OATMEAL - UNII:8PI54V663Y) OATMEAL1 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    DISTEARYLDIMONIUM CHLORIDE (UNII: OM9573ZX3X)  
    ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    STEARETH-21 (UNII: 53J3F32P58)  
    PANTHENOL (UNII: WV9CM0O67Z)  
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    CERAMIDE 3 (UNII: 4370DF050B)  
    CERAMIDE 6 II (UNII: F1X8L2B00J)  
    CERAMIDE 1 (UNII: 5THT33P7X7)  
    PHYTOSPHINGOSINE (UNII: GIN46U9Q2Q)  
    CHOLESTEROL (UNII: 97C5T2UQ7J)  
    SODIUM LAUROYL LACTYLATE (UNII: 7243K85WFO)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    OAT KERNEL OIL (UNII: 3UVP41R77R)  
    OAT (UNII: Z6J799EAJK)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63940-429-12140 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34709/01/2014
    Labeler - Harmon Stores Inc. (804085293)
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