Label: BABYGANICS ECZEMA- oatmeal lotion

  • NDC Code(s): 59062-1303-1
  • Packager: KAS Direct LLC dba BabyGanics
  • 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 04/14

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

  • SPL UNCLASSIFIED SECTION

    Drug Facts

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  • Active ingredient

    Colloidal oatmeal 1%

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  • Purpose

    Skin protectant

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  • Uses

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

    • rashes
    • eczema
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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

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

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  • Directions

    • apply as needed
    • massage into baby's skin, especially after bathing - perfect for face and body
    • for use on mild to moderate eczema or as directed by a physician
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  • Other information

    Store at room temperature 59-77°F (15-25°C)

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  • Inactive ingredients

    water, butyrospermum parkii (shea) butter, cetearyl alcohol, cetyl alcohol, isopropyl palmitate, glycerin, glyceryl stearate, theobroma cacao (cocoa) seed butter, hydrolyzed oats, solanum lycopersicum (tomato) seed oil, helianthus annuus (sunflower) seed oil, vaccinium macrocarpon (cranberry) seed oil, nigella sativa (black cumin) seed oil, rubus idaeus (red raspberry) seed oil, cetearyl glucoside, tocopherol, glyceryl dilaurate, caprylyl glycol, xanthan gum, sodium phytate, ethylhexylglycerin, citric acid, sodium hydroxymethylglycinate

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  • SPL UNCLASSIFIED SECTION

    Dist. by:
    KAS Direct, LLC.
    Hicksville, NY 11801

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  • PRINCIPAL DISPLAY PANEL - 85 g Tube Label

    extra
    soothing

    babyganics®

    eczema care
    skin protectant cream

    with colloidal oatmeal ∙ relieves dry,
    itchy, irritated skin ∙ non–allergenic
    pediatrician & dermatologist tested

    no: cortisone, steroids, parabens,
    sulfates, phthalates or fragrances

    + NeoNourish* Natural Seed Oil Blend

    3 OZ (85g)

    Principal Display Panel - 85 g Tube Label
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  • INGREDIENTS AND APPEARANCE
    BABYGANICS ECZEMA 
    oatmeal lotion
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:59062-1303
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    OATMEAL (UNII: 8PI54V663Y) (OATMEAL - UNII:8PI54V663Y) OATMEAL 10 mg  in 1 g
    Inactive Ingredients
    Ingredient Name Strength
    WATER (UNII: 059QF0KO0R)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    COCOA BUTTER (UNII: 512OYT1CRR)  
    OAT (UNII: Z6J799EAJK)  
    NIGELLA SATIVA SEED OIL (UNII: CS4U38E731)  
    CARROT SEED OIL (UNII: 595AO13F11)  
    CHIA SEED OIL (UNII: MC2LH51BO7)  
    RASPBERRY SEED OIL (UNII: 9S8867952A)  
    CRANBERRY SEED OIL (UNII: 73KDS3BW5E)  
    CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    GLYCERYL DILAURATE (UNII: MFL3ZIE8SK)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    PHYTATE SODIUM (UNII: 88496G1ERL)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    SODIUM HYDROXYMETHYLGLYCINATE (UNII: DIG6BWZ9XT)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:59062-1303-1 85 g in 1 TUBE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC MONOGRAPH FINAL part347 06/21/2013
    Labeler - KAS Direct LLC dba BabyGanics (002764605)
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