Label: EVEREDEN HEALING ECZEMA TREATMENT- colloidal oatmeal cream

  • Category: HUMAN OTC DRUG LABEL

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 March 15, 2023

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

View All Sections
  • STATEMENT OF IDENTITY

    Primary

  • ACTIVE INGREDIENT

    Colloidal Oatmeal 1%

  • PURPOSE

    Skin Protectant

  • USES

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

  • WARNINGS

    • For external use only.
    • When using this product: Do not get into eyes.
    • Stop use and ask a doctor if: - conditions worsen. - symptoms last more than 7 days or clear up and occur again within a few days.
  • WARNINGS

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

  • DIRECTIONS

    Apply as needed

  • INACTIVE INGREDIENTS

    Water(Aqua), Octyldodecanol, Glycerin, Dimethicone, Butyrospermum Parkii (Shea) Butter, Squalane, 1,2-Hexanediol, Helianthus Annuus (Sunflower) Seed Oil Unsaponifiables, Cetearyl Olivate, Cetearyl Alcohol, Sorbitan Olivate, Simmondsia Chinensis (Jojoba) Seed Oil, Cucumis Sativus (Cucumber) Fruit Extract, Cocos Nucifera (Coconut) Oil, Spent Grain Wax, Argania Spinosa Kernel Oil, Ceramide AP, Ceramide EOP, Ceramide NP, Sodium PCA, Sodium Hyaluronate, Quercetin, Zinc Oxide, Hydroxyproline, Proline, Panthenol, Sodium Lauroyl Lactylate, Hydroxyacetophenone, Phytosphingosine, Menthyl Ethylamido Oxalate, Cholesterol, Tetrasodium Glutamate Diacetate, Sodium Stearoyl Glutamate, Xanthan Gum, Allantoin, Carbomer, Sodium Hydroxide

  • PRINCIPAL DISPLAY PANEL

    Secondary

  • INGREDIENTS AND APPEARANCE
    EVEREDEN HEALING ECZEMA TREATMENT 
    colloidal oatmeal cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72113-106
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OATMEAL (UNII: 8PI54V663Y) (OATMEAL - UNII:8PI54V663Y) OATMEAL1 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    OCTYLDODECANOL (UNII: 461N1O614Y)  
    SQUALANE (UNII: GW89575KF9)  
    SORBITAN OLIVATE (UNII: MDL271E3GR)  
    CUCUMIS SATIVUS WHOLE (UNII: 50560UL2YV)  
    ARGANIA SPINOSA SEED (UNII: 8H7X7XB54H)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    BUTYROSPERMUM PARKII (SHEA) BUTTER UNSAPONIFIABLES (UNII: 0C9AC7D6XU)  
    1,2-HEXANEDIOL (UNII: TR046Y3K1G)  
    HELIANTHUS ANNUUS SEED WAX (UNII: 42DG15CHXV)  
    COCOS NUCIFERA WHOLE (UNII: 245J88W96L)  
    SIMMONDSIA CHINENSIS SEED (UNII: D24K2Q1F6H)  
    CERAMIDE AP (UNII: F1X8L2B00J)  
    TETRASODIUM GLUTAMATE DIACETATE (UNII: 5EHL50I4MY)  
    ARGAN OIL (UNII: 4V59G5UW9X)  
    SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)  
    ALLANTOIN (UNII: 344S277G0Z)  
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    CETEARYL OLIVATE (UNII: 58B69Q84JO)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    CERAMIDE NP (UNII: 4370DF050B)  
    ZINC OXIDE (UNII: SOI2LOH54Z)  
    PHYTOSPHINGOSINE (UNII: GIN46U9Q2Q)  
    CHOLESTEROL (UNII: 97C5T2UQ7J)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    CERAMIDE 1 (UNII: 5THT33P7X7)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    QUERCETIN (UNII: 9IKM0I5T1E)  
    HYDROXYPROLINE (UNII: RMB44WO89X)  
    PROLINE (UNII: 9DLQ4CIU6V)  
    PANTHENOL (UNII: WV9CM0O67Z)  
    SODIUM LAUROYL LACTYLATE (UNII: 7243K85WFO)  
    HYDROXYACETOPHENONE (UNII: G1L3HT4CMH)  
    MENTHYL ETHYLAMIDO OXALATE (UNII: G2MB8B7PSM)  
    SODIUM STEAROYL GLUTAMATE (UNII: 65A9F4P024)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    Product Characteristics
    ColorwhiteScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72113-106-031 in 1 CARTON02/01/2022
    150 mL in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34702/01/2022
    Labeler - Eden Brands, Inc. (081062339)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials

More Info on this Drug

Get Label RSS Feed, View NDC Code(s)NEW!