EVEREDEN HEALING ECZEMA TREATMENT- colloidal oatmeal cream 
Eden Brands, Inc.

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.

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Evereden Healing Eczema Treatment

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

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

Secondary

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)

Revised: 3/2023
Document Id: f6f55fee-17fc-1cbb-e053-6294a90a7263
Set id: d43f0eaa-aab0-eaff-e053-2995a90ac5c8
Version: 2
Effective Time: 20230315
 
Eden Brands, Inc.