Label: MATYS BABY ECZEMA RELIEF- colloidal oatmeal ointment

  • NDC Code(s): 72827-103-05
  • Packager: Matys Healthy Products 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 June 4, 2021

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  • Drug Facts

  • Active Ingredient

    Colloidal Oatmeal 0.1%

  • Purpose

    Skin Protectant

  • Uses

    • Temporarily protects and helps relieve minor skin irritation and itching due to Eczema and rashes

  • 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

    Do not use on
    • deep puncture wounds
    • serious burns • animal bites

    Keep out of reach of children
    if swallowed get medical help or contact Poison Control Center.

  • Directions

    • Apply as needed

    • Any ingredient, even in natural products, may not agree with your child's skin. That's why we believe it's best to be cautious when using new products. We recommend trying our ointment on a small patch of skin first to be sure your child does not react.

  • Other Information

    Store at room temperature.

  • Inactive Ingredients

    Olive (Olea Europaea) Oil, Coconut (Cocos Nucifera) Oil, Beeswax (Cera Alba), Castor (Ricinus Communis) Oil, Jojoba (Simmondsia Chinensis) Oil, Calendula (Calendula Officinalis) Oil, Carnauba Wax (Copernicia Cerifera), Lavender (Lavandula Angustifolia) Oil, Lemon Balm (Melissa Officinalis) Extract, Dill Weed (Anethum Graveolens) Oil, Bergamot (Citrus Bergamia) Oil, Vitamin E (Tocopherol), Chamomile Roman (Anthemis Nobilis) Oil

  • Questions?

    1-888-900-6289

  • SPL UNCLASSIFIED SECTION

    ALL NATURAL

    RELIEVES & PROTECTS IRRITATED & ITCHY SKIN

    NATURALLY SOOTHES & CALMS

    CALENDULA & CHAMOMILE

    FOR BABIES 3MO. +OLDER

    WE CURATE OUR INGREDIENTS FROM MOTHER NATURE'S CUPBOARD.

    Our all natural ingredients may be harvested or mined and then purified.

    NO PETROLEUM • NO PARABENS • NO PHTHALATES
    NO FRAGRANCES • NO HYDROGENATED OILS

    Pediatrician Tested     

    Gluten Free   

    No Animal Testing

    Distributed By
    Maty's Healthy Products, LLC
    Boulder, CO 80301
    888-900-6289 · matys.com

    MADE IN AMERICA
    WITH GLOBAL INGREDIENTS

    vitamin angels®

    We donate a portion of every sale to Vitamin Angels

  • Packaging

    Eczema1

  • INGREDIENTS AND APPEARANCE
    MATYS BABY ECZEMA RELIEF 
    colloidal oatmeal ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72827-103
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OATMEAL (UNII: 8PI54V663Y) (OATMEAL - UNII:8PI54V663Y) OATMEAL0.1 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    OLIVE OIL (UNII: 6UYK2W1W1E)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    YELLOW WAX (UNII: 2ZA36H0S2V)  
    CASTOR OIL (UNII: D5340Y2I9G)  
    JOJOBA OIL (UNII: 724GKU717M)  
    CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    LAVENDER OIL (UNII: ZBP1YXW0H8)  
    MELISSA OFFICINALIS LEAF (UNII: 50D2ZE9219)  
    DILLWEED OIL (UNII: 0MYU0F0FNV)  
    BERGAMOT OIL (UNII: 39W1PKE3JI)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    CHAMAEMELUM NOBILE FLOWER OIL (UNII: UB27587839)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72827-103-05106 g in 1 TUBE; Type 0: Not a Combination Product06/01/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34706/01/2021
    Labeler - Matys Healthy Products LLC (830622358)
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