Label: ECZEMA CARE SKIN PROTECTANT- oatmeal lotion

  • NDC Code(s): 59062-1305-8
  • Packager: KAS Direct LLC dba BabyGanics
  • 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 July 17, 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
    • 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) butter1, cetearyl alcohol, cetyl alcohol, isopropyl palmitate, glycerin1, glyceryl stearate, theobroma cacao (cocoa) seed butter1, hydrolyzed oats, solanum lycopersicum (tomato) seed oil, helianthus annuus (sunflower) seed oil1, vaccinium macrocarpon (cranberry) seed oil, nigella sativa (black cumin) seed oil1, rubus idaeus (red raspberry) seed oil, cetearyl glucoside, tocopherol, glyceryl dilaurate, caprylyl glycol, xanthan gum, sodium hydroxide, sodium phytate, triethyl citrate, ethylhexylglycerin, benzoic acid.

    1
    Certified Organic Ingredient
    Unless otherwise specified, product not labeled as organic
  • SPL UNCLASSIFIED SECTION

    dist. by KAS direct, LLC
    Westbury, NY 11590

  • PRINCIPAL DISPLAY PANEL - 226 g Tube Label

    ACCEPTED
    NATIONALECZEMA.ORG
    NATIONAL
    ECZEMA
    ASSOCIATION

    babyganics

    eczema care skin
    protectant cream

    fragrance free

    relieves dry, itchy,
    irritated skin
    non-allergenic ∙
    pediatrician &
    dermatologist tested

    formulated with:
    colloidal oatmeal*

    formulated without:
    cortisone, steroids,
    parabens, phthalates
    or fragrances

    Discover which of
    our ingredients are
    Certified Organic
    on back panel.

    Net wt 8 OZ (226 g)

    PRINCIPAL DISPLAY PANEL - 226 g Tube Label
  • INGREDIENTS AND APPEARANCE
    ECZEMA CARE SKIN PROTECTANT 
    oatmeal lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59062-1305
    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)  
    TRIETHYL CITRATE (UNII: 8Z96QXD6UM)  
    BENZOIC ACID (UNII: 8SKN0B0MIM)  
    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)  
    TOMATO (UNII: Z4KHF2C175)  
    SUNFLOWER OIL (UNII: 3W1JG795YI)  
    SOYBEAN OIL (UNII: 241ATL177A)  
    Sodium Hydroxide (UNII: 55X04QC32I)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59062-1305-8226 g in 1 TUBE; Type 0: Not a Combination Product04/08/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart34704/08/2019
    Labeler - KAS Direct LLC dba BabyGanics (002764605)
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