Label: BABYGANICS ECZEMA- oatmeal lotion

  • NDC Code(s): 59062-1303-1
  • Packager: KAS Direct LLC dba BabyGanics
  • 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 February 4, 2020

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient

    Colloidal oatmeal 1%

  • Purpose

    Skin protectant

  • Uses

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

    • rashes
    • eczema
  • 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
    • 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
  • Other information

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

  • 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

  • SPL UNCLASSIFIED SECTION

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

  • 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
  • INGREDIENTS AND APPEARANCE
    BABYGANICS ECZEMA 
    oatmeal lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59062-1303
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OATMEAL (UNII: 8PI54V663Y) (OATMEAL - UNII:8PI54V663Y) OATMEAL10 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    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 CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59062-1303-185 g in 1 TUBE; Type 0: Not a Combination Product06/21/2013
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart34706/21/2013
    Labeler - KAS Direct LLC dba BabyGanics (002764605)
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