Label: ECZEMA- oatmeal lotion/shampoo

  • NDC Code(s): 52915-010-05, 52915-010-19, 52915-010-85
  • Packager: ORGANIC & SUSTAINABLE BEAUTY
  • 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 November 5, 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
    • Poison ivy, oak, or sumac
    • Insect bites
  • 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)

  • 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.
  • Other information

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

  • 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.

  • PRINCIPAL DISPLAY PANEL - 562 mL Bottle Label

    CALIF♥RNIA BABY®

    TRUSTED
    SINCE 1995

    eczema therapy

    SHAMPOO &
    BODYWASH
    SKIN PROTECTANT

    GLUTEN FREE + STEROID FREE

    GENTLE • NON-DRYING • NO ADDED FRAGRANCE

    BABIES + KIDS + ADULTS

    ALLERGY
    TESTED

    © 2019

    562 mL/19 fl. oz.

    Principal Display Panel - 562 mL Bottle Label
  • INGREDIENTS AND APPEARANCE
    ECZEMA 
    oatmeal lotion/shampoo
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52915-010
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OATMEAL (UNII: 8PI54V663Y) (OATMEAL - UNII:8PI54V663Y) OATMEAL10 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    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 WHOLE (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 CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:52915-010-19562 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product10/01/2012
    2NDC:52915-010-0514 mL in 1 TUBE; Type 0: Not a Combination Product10/01/2012
    3NDC:52915-010-85251 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product10/01/2012
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart34710/01/2012
    Labeler - ORGANIC & SUSTAINABLE BEAUTY (020085717)
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