Label: ECZEMA- oatmeal lotion/shampoo

  • NDC Code(s): 52915-010-05, 52915-010-19
  • Packager: ORGANIC & SUSTAINABLE BEAUTY
  • 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 09/13

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
    • poison ivy, oak, or sumac
    • insect bites
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  • Warnings

    External use only.

    When using this product

    • patch test before use
    • keep out of eyes
    • clean with soap and water to remove
    • to avoid slipping, use mat in tub or shower

    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 Poison Control within the U.S. (1-800-222-1222)

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  • Directions

    • dispense a dime-to-quarter sized amount into palm, massage into wet hair starting at the scalp and working to the ends. Rinse.
    • for extra cleansing, allow to sit for 30 seconds and then rinse.
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  • Other information

    You may report a serious adverse reaction event from using this product to: 5933 Bowcroft St. Los Angeles, CA 90016

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  • Inactive ingredients

    Water, decyl glucoside, lauryl glucoside, quillaja saponaria bark extract, glycerine, allantoin, calendula officinalis flower extract, viola tricolor extract, yucca schidigera root extract, aloe barbadensis leaf juice, simmondsia chinensis (jojoba) seed oil, hydrolyzed quinoa, xanthan gum, panthenol, phytic acid, gluconolactone, sodium benzoate.

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  • PRINCIPAL DISPLAY PANEL - 562 mL Bottle Label

    CALIF♥RNIA BABY®
    safe ♥ natural ♥ fun

    NEW &
    IMPROVED!

    therapeutic relief

    COLLOIDAL OATMEAL (CONTAINS GLUTEN)

    ECZEMA
    SHAMPOO & BODYWASH

    SKIN PROTECTANT • GENTLY CLEANSES SENSITIVE OR IRRITATED SKIN
    DUE TO ECZEMA • HELPS HEAL & PROTECT DELICATE SKIN
    NO SULFATES, STEROIDS OR ALCOHOL

    NO ADDED FRAGRANCE
    HAIR, FACE & BODY

    ALLERGY
    TESTED

    • for babies • kids •
    • sensitive adults •

    562 mL / 19 Fl. Oz.

    Principal Display Panel - 562 mL Bottle Label
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  • INGREDIENTS AND APPEARANCE
    ECZEMA 
    oatmeal lotion/shampoo
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:52915-010
    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 mL
    Inactive Ingredients
    Ingredient Name Strength
    Water (UNII: 059QF0KO0R)  
    decyl glucoside (UNII: Z17H97EA6Y)  
    lauryl glucoside (UNII: 76LN7P7UCU)  
    quillaja saponaria bark (UNII: 8N0K3807ZW)  
    glycerin (UNII: PDC6A3C0OX)  
    allantoin (UNII: 344S277G0Z)  
    calendula officinalis flower (UNII: P0M7O4Y7YD)  
    viola tricolor (UNII: 9Q24RAI43V)  
    yucca schidigera root (UNII: E2H9ET15AT)  
    aloe vera leaf (UNII: ZY81Z83H0X)  
    jojoba oil (UNII: 724GKU717M)  
    quinoa oil (UNII: M437LS0K52)  
    xanthan gum (UNII: TTV12P4NEE)  
    panthenol (UNII: WV9CM0O67Z)  
    fytic acid (UNII: 7IGF0S7R8I)  
    gluconolactone (UNII: WQ29KQ9POT)  
    sodium benzoate (UNII: OJ245FE5EU)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:52915-010-19 562 mL in 1 BOTTLE, PUMP
    2 NDC:52915-010-05 14 mL in 1 TUBE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC MONOGRAPH FINAL part347 10/01/2012
    Labeler - ORGANIC & SUSTAINABLE BEAUTY (020085717)
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