Label: ECZEMA RELIEF SOOTHING WASH 2% COLLOIDAL OATMEAL- colloidal oatmeal gel
- NDC Code(s): 83092-104-10
- Packager: Three Dog Beauty LLC
- 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
- PURPOSE
- USES
- WARNINGS
- KEEP OUT OF REACH OF CHILDREN
- DIRECTIONS
- OTHER INFORMATION
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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
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INGREDIENTS AND APPEARANCE
ECZEMA RELIEF SOOTHING WASH 2% COLLOIDAL OATMEAL
colloidal oatmeal gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:83092-104 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OATMEAL (UNII: 8PI54V663Y) (OATMEAL - UNII:8PI54V663Y) OATMEAL 2 g in 100 mL Inactive Ingredients Ingredient Name Strength 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 Code Package Description Marketing Start Date Marketing End Date 1 NDC:83092-104-10 295 mL in 1 TUBE; Type 0: Not a Combination Product 09/28/2022 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final M016 09/28/2022 Labeler - Three Dog Beauty LLC (111157953) Registrant - Three Dog Beauty LLC (111157953)