ECZEMA RELIEF SOOTHING WASH 2% COLLOIDAL OATMEAL- colloidal oatmeal gel
Three Dog Beauty LLC

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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THREE DOG BEAUTY - NAKERY BEAUTY - ECZEMA RELIEF SOOTHING WASH (83092-104)

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. 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

01b LBL_Eczema Wash_10oz

ECZEMA RELIEF SOOTHING WASH 2% COLLOIDAL OATMEAL
colloidal oatmeal gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:83092-104
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
OATMEAL (UNII: 8PI54V663Y) (OATMEAL - UNII:8PI54V663Y)	OATMEAL	2 g in 100 mL

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:83092-104-10	295 mL in 1 TUBE; Type 0: Not a Combination Product	09/28/2022

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	M016	09/28/2022

Labeler - Three Dog Beauty LLC (111157953)

Registrant - Three Dog Beauty LLC (111157953)