Label: SATYA ORGANIC FRAGRANCE-FREE ECZEMA RELIEF- colloidal oatmeal ointment

  • 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 January 16, 2023

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredient

    Colloidal oatmeal 1%

  • PURPOSE

    Purpose

    Skin protectant

  • INDICATIONS & USAGE

    Uses

    temporarily protects and helps relieve minor skin irritation and itching due to:

    • rashes • eczema • poison ivy, oak or sumac • insect bites

  • WARNINGS

    Warnings

    For external use only.

  • WHEN USING

    When using this product do not get into eyes

  • STOP USE

    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

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

  • DOSAGE & ADMINISTRATION

    Directions

    apply as needed

  • INACTIVE INGREDIENT

    InactiveingredientsBeeswax*, Calendula Flower Oil*, Jojoba Oil*, Sweet Almond Oil.*

    * USDA certified organic ingredient.

  • SPL UNCLASSIFIED SECTION

    Questions? 778.655.9006

    @SATYAORGANIC

  • PRINCIPAL DISPLAY PANEL

    Satya

    ORGANIC

    FRAGRANCE-FREE

    ECZEMABox

    RELIEF

    Skin Protectant Balm

    Temporarily protects and helps relieve minor skin irritations and itching due to:

    eczema ♦ rashes ♦ insect bites ♦ poison ivy, oat or sumac

    Colloidal Oatmeal 1%

    USDA Certified Organic    NDC 82590-030-01

    NET CONTETNS 1 FL OZ (30 ML) BALM

  • INGREDIENTS AND APPEARANCE
    SATYA ORGANIC FRAGRANCE-FREE ECZEMA RELIEF 
    colloidal oatmeal ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:82590-030
    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
    SYNTHETIC BEESWAX (UNII: 08MNR5YE2R)  
    CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)  
    JOJOBA OIL (UNII: 724GKU717M)  
    ALMOND OIL (UNII: 66YXD4DKO9)  
    Product Characteristics
    ColoryellowScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:82590-030-0130 mL in 1 TUBE; Type 0: Not a Combination Product03/18/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34703/01/2022
    Labeler - Satya Organic Inc. (203272521)
    Registrant - Satya Organic Inc. (203272521)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vegewax Candleworx Ltd201050882manufacture(82590-030)
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