Label: ECZEMA- oatmeal cream

  • NDC Code(s): 52915-120-02, 52915-120-05, 52915-120-19, 52915-120-45
  • Packager: ORGANIC & SUSTAINABLE BEAUTY
  • 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 November 9, 2020

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient

    Colloidal Oatmeal 1%

  • Purpose

    Skin Protectant

  • Uses

    Temporarily protects & helps relieve minor skin irritation and itching due to:

    • Rashes
    • Eczema
    • Poison ivy, oak, or sumac
    • Insect bites
  • 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 Poison Control within the U.S. (1-800-222-1222)

  • Directions

    Apply liberally onto desired area

    • Reapply as needed. Children under 6 months: ask a doctor. Use in combination with our Eczema Shampoo & Bodywash.
  • 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, calendula officinalis flower extract, caprylic/capric triglyceride, cetyl alcohol, stearic acid, cetearyl olivate, sorbitan olivate, canola oil, allantoin, viola tricolor extract, yucca schidigera root extract, aloe barbadensis leaf juice, rosmarinus officinalis leaf extract, lavandula angustifolia (lavender) oil, salvia sclarea (clary) oil, phytic acid, caprylhydroxamic acid, glyceryl caprylate.

  • PRINCIPAL DISPLAY PANEL - 133 mL Container Label

    CALIF♥RNIA BABY®
    TRUSTED SINCE 1995

    therapeutic relief™

    GLUTEN-FREE!
    ECZEMA
    CREAM
    SKIN PROTECTANT

    OATMEAL & CALENDULA
    HELPS HEAL & PROTECT DELICATE SKIN
    FOR BABIES, KIDS & SENSITIVE ADULTS

    ALLERGY
    TESTED

    133 mL/4.5 fl. oz.

    PRINCIPAL DISPLAY PANEL - 133 mL Container Label
  • INGREDIENTS AND APPEARANCE
    ECZEMA 
    oatmeal cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52915-120
    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)  
    medium-chain triglycerides (UNII: C9H2L21V7U)  
    cetyl alcohol (UNII: 936JST6JCN)  
    stearic acid (UNII: 4ELV7Z65AP)  
    cetearyl olivate (UNII: 58B69Q84JO)  
    sorbitan olivate (UNII: MDL271E3GR)  
    canola oil (UNII: 331KBJ17RK)  
    allantoin (UNII: 344S277G0Z)  
    calendula officinalis flower (UNII: P0M7O4Y7YD)  
    VIOLA TRICOLOR WHOLE (UNII: 9Q24RAI43V)  
    yucca schidigera root (UNII: E2H9ET15AT)  
    aloe vera leaf (UNII: ZY81Z83H0X)  
    rosemary (UNII: IJ67X351P9)  
    lavender oil (UNII: ZBP1YXW0H8)  
    clary sage oil (UNII: 87L0D4U3M0)  
    fytic acid (UNII: 7IGF0S7R8I)  
    caprylhydroxamic acid (UNII: UPY805K99W)  
    GLYCERYL MONOCAPRYLATE (UNII: TM2TZD4G4A)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:52915-120-45133 mL in 1 CONTAINER; Type 0: Not a Combination Product12/01/2012
    2NDC:52915-120-0514 mL in 1 TUBE; Type 0: Not a Combination Product12/01/2012
    3NDC:52915-120-0257 mL in 1 JAR; Type 0: Not a Combination Product12/01/2012
    4NDC:52915-120-19562 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product12/01/201207/31/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart34712/01/2012
    Labeler - ORGANIC & SUSTAINABLE BEAUTY (020085717)
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