Label: ECZEMA RELIEF SOOTHING WASH 2% COLLOIDAL OATMEAL- colloidal oatmeal gel

  • 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 3, 2022

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  • ACTIVE INGREDIENT

    COLLOIDAL OATMEAL 2%

  • PURPOSE

    SKIN PROTECTANT

  • USES

    TEMPORARILY PROTECTS AND HELPS RELIEVE MINOR SKIN IRRITATION AND ITCHING DUE TO ECZEMA.

  • WARNINGS

    • FOR EXTERNAL USE ONLY.

    WHEN USING THIS PRODUCT

    • AVOID CONTACT WITH 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

    KEEP OUT OF REACH OF CHILDREN. IF SWALLOWED, GET MEDICAL HELP OR CONTACT POISON CONTROL CENTER RIGHT AWAY.

  • DIRECTIONS

    • APPLY AS NEEDED OR AS DIRECTED BY A DOCTOR.
    • CHILDREN UNDER 2 YEARS: CONSULT A DOCTOR
  • OTHER INFORMATION

    STORE AT ROOM TEMPERATURE.

  • INACTIVE INGREDIENTS

    WATER, SODIUM COCOYL ISETHIONATE, COCAMIDOPROPYL HYDROXYSULTAINE, SODIUM LAURYL SARCOSINATE, GLYCERIN, DECYL GLUCOSIDE, GLYCOL STEARATE, GLYCERYL CAPRYLATE, ARGANIA SPINOSA KERNEL OIL, CAPRYLHYDROXAMIC ACID, ALOE BARBADENSIS LEAF EXTRACT, SIMMONDSIA CHINENSIS (JOJOBA) SEED OIL, HELIANTHUS ANNUUS (SUNFLOWER) SEED OIL, HIBISCUS SABDARIFFA FLOWER EXTRACT, PANTHENOL, BROMELAIN, NIACINAMIDE, GUAR HYDROXYPROPYLTRIMONIUM CHLORIDE, PHOSPHOLIPIDS, SPHINGOLIPIDS, TOCOPHEROL

  • QUESTIONS?

    WWW.NAKERYBEAUTY.COM

  • PRINCIPAL DISPLAY PANEL

    01b LBL_Eczema Wash_10oz

  • INGREDIENTS AND APPEARANCE
    ECZEMA RELIEF SOOTHING WASH  2% COLLOIDAL OATMEAL
    colloidal oatmeal gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:83092-104
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OATMEAL (UNII: 8PI54V663Y) (OATMEAL - UNII:8PI54V663Y) OATMEAL2 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    GLYCERYL CAPRYLATE (UNII: TM2TZD4G4A)  
    ARGAN OIL (UNII: 4V59G5UW9X)  
    CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W)  
    PANTHENOL (UNII: WV9CM0O67Z)  
    BROMELAINS (UNII: U182GP2CF3)  
    SOY SPHINGOLIPIDS (UNII: P491F5HP1U)  
    EGG PHOSPHOLIPIDS (UNII: 1Z74184RGV)  
    NIACINAMIDE (UNII: 25X51I8RD4)  
    GLYCOL STEARATE (UNII: 0324G66D0E)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    SUNFLOWER OIL (UNII: 3W1JG795YI)  
    GUAR HYDROXYPROPYLTRIMONIUM CHLORIDE (1.7 SUBSTITUENTS PER SACCHARIDE) (UNII: B16G315W7A)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    DECYL GLUCOSIDE (UNII: Z17H97EA6Y)  
    JOJOBA OIL (UNII: 724GKU717M)  
    HIBISCUS SABDARIFFA FLOWER (UNII: 45TGG6IU6M)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM COCOYL ISETHIONATE (UNII: 518XTE8493)  
    COCAMIDOPROPYL HYDROXYSULTAINE (UNII: 62V75NI93W)  
    SODIUM LAURYL SARCOSINATE (UNII: 5PGH842FAU)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:83092-104-10295 mL in 1 TUBE; Type 0: Not a Combination Product09/28/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalM01609/28/2022
    Labeler - Three Dog Beauty LLC (111157953)
    Registrant - Three Dog Beauty LLC (111157953)
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