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

  • 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.

  • OTHER INFORMATION

    STORE AT ROOM TEMPERATURE.

  • INACTIVE INGREDIENTS

    WATER, BUTYROSPERMUM PARKII (SHEA) BUTTER, CARTHAMUS TINCTORIUS (SAFFLOWER) SEED OIL, CETEARYL OLIVATE, SORBITAN OLIVATE, CHENOPODIUM QUINOA SEED OIL, COCOGLYCERIDES, GLYCERIN, CETEARYL ALCOHOL, GLYCERYL LAURATE, GLYCERYL STEARATE, HELIANTHUS ANNUUS (SUNFLOWER) SEED OIL, HIPPOPHAE RHAMNOIDES (SEABUCKTHORN) SEED OIL, SIMMONDSIA CHINENSIS (JOJOBA) SEED OIL, LIMNANTHES ALBA (MEADOWFOAM) SEED OIL, SQUALANE, GLYCERYL CAPRYLATE, PROPANEDIOL, ALOE BARBADENSIS LEAF EXTRACT, POTASSIUM SORBATE, SALVIA HISPANICA SEED OIL, XANTHAN GUM, HYDROXYETHYLCELLULOSE, CAPRYLHYDROXAMIC ACID, THEOBROMA CACOA (COCOA) SEED BUTTER, TOCOPHEROL

  • QUESTIONS?

    WWW.NAKERYBEAUTY.COM

  • PRINCIPAL DISPLAY PANEL

    01b LBL_Eczema Cream_6oz

  • INGREDIENTS AND APPEARANCE
    ECZEMA RELIEF SOOTHING  2% COLLOIDAL OATMEAL
    colloidal oatmeal cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:83092-105
    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
    HYDROXYETHYL CELLULOSE, UNSPECIFIED (UNII: T4V6TWG28D)  
    COCOA BUTTER (UNII: 512OYT1CRR)  
    CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W)  
    SAFFLOWER OIL (UNII: 65UEH262IS)  
    SALVIA HISPANICA SEED (UNII: NU0OLX06F8)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    GLYCERYL CAPRYLATE (UNII: TM2TZD4G4A)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    CETEARYL OLIVATE (UNII: 58B69Q84JO)  
    SORBITAN OLIVATE (UNII: MDL271E3GR)  
    CHENOPODIUM QUINOA SEED (UNII: OO4K72NZ2X)  
    COCO-GLYCERIDES (UNII: ISE9I7DNUG)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    GLYCERYL LAURATE (UNII: Y98611C087)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    SUNFLOWER OIL (UNII: 3W1JG795YI)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    JOJOBA OIL (UNII: 724GKU717M)  
    HIPPOPHAE RHAMNOIDES SEED OIL (UNII: T53SBG6741)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    WATER (UNII: 059QF0KO0R)  
    MEADOWFOAM SEED OIL (UNII: 412ZHA4T4Y)  
    SQUALANE (UNII: GW89575KF9)  
    PROPANEDIOL (UNII: 5965N8W85T)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:83092-105-06177 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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