Label: EARTH MAMA ECZEMA CREAM- colloidal oatmeal cream

  • NDC Code(s): 72812-151-01
  • Packager: Earth Mama Angel Baby, LLC
  • 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 August 30, 2023

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  • Drug Facts

  • Active Ingredient

    Colloidal Oatmeal* 5%

  • 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. For use on mild to moderate eczema or as directed by a physician.

  • 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 product is swallowed, get medical help or contact Poison Control Center right away.

  • Directions

    Apply as needed.

  • Other Information

    Store at room temperature.

  • Inactive Ingredients

    Helianthus Annuus (Sunflower) Seed Oil*, Cocos Nucifera (Coconut) Oil*, Caprylic/Capric Triglyceride*, Olea Europaea (Olive) Fruit Oil*, Beeswax*, Butyrospermum Parkii (Shea) Butter*, Simmondsia Chinensis (Jojoba) Seed Oil*, Oenothera Biennis (Evening Primrose) Oil*, Aloe Barbadensis Leaf Powder*, Aspalathus Linearis (Rooibos) Leaf Extract*, Nigella Sativa (Black Cumin) Seed Extract*, Tocopherol, Zinc Oxide

    *Organic

  • Questions or comments?

    503-607-0607 or earthmama.com

  • SPL UNCLASSIFIED SECTION

    THERAPEUTIC

    ITCH RELIEF

    Pediatrician & Dermatologist Tested

    Contains Organic Rooibos & Black Cumin Seed

    Steroid-free, NO Artificial Preservatives or Fragrance

    NSF
    contains organic ingredients

    FOR EVERYONE AND THEIR MOTHER.

    ​• Relieves itch on contact
    • Moisturizing skin protectant
    • Relieves itch associated with eczema flare up

    Distributed by Earth Mama Angel Baby® LLC
    9866 SE Empire Ct. • Clackamas, OR 97015 USA

    Certified to the NSF/ANSI 305 Standard by Oregon Tilth

    Awarded the National Eczema Association

    Seal of AcceptanceTM

    Leaping Bunny Certified

  • Packaging

    IMAGE

  • INGREDIENTS AND APPEARANCE
    EARTH MAMA ECZEMA CREAM 
    colloidal oatmeal cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72812-151
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OATMEAL (UNII: 8PI54V663Y) (OATMEAL - UNII:8PI54V663Y) OATMEAL50 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    SUNFLOWER OIL (UNII: 3W1JG795YI)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    OLIVE OIL (UNII: 6UYK2W1W1E)  
    YELLOW WAX (UNII: 2ZA36H0S2V)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    JOJOBA OIL (UNII: 724GKU717M)  
    EVENING PRIMROSE OIL (UNII: 3Q9L08K71N)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    ASPALATHUS LINEARIS LEAF (UNII: H7UGK1GJCU)  
    NIGELLA SATIVA SEED (UNII: 4LVZ0Z0ITT)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    ZINC OXIDE (UNII: SOI2LOH54Z)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72812-151-0185 g in 1 TUBE; Type 0: Not a Combination Product01/01/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34701/01/2021
    Labeler - Earth Mama Angel Baby, LLC (603560686)
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