ECZEMA RELIEF SOOTHING 2% COLLOIDAL OATMEAL- colloidal oatmeal cream 
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 CREAM (83092-105)

ACTIVE INGREDIENT

COLLOIDAL OATMEAL 2%

PURPOSE

SKIN PROTECTANT

USES

TEMPORARILY PROTECTS AND HELPS RELIEVE MINOR SKIN IRRITATION AND ITCHING DUE TO ECZEMA.

WARNINGS

WHEN USING THIS PRODUCT

STOP USE AND ASK A DOCTOR IF

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

01b LBL_Eczema Cream_6oz

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)

Revised: 11/2022
Document Id: ec9a6190-9bbe-96b4-e053-2995a90a8179
Set id: ec9a59c4-5dd5-9879-e053-2a95a90a544a
Version: 1
Effective Time: 20221103
 
Three Dog Beauty LLC