DAILY MOISTURIZING - OATMEAL- dimethicone lotion 
Greenbrier International

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.

----------

Daily Moisturizing Oatmeal

Active Ingredient                  Purpose

Dimethicone 1/3% ...... Skin Protectant

XtraCare Skin Relief Oatmeal Daily Moisturizing Lotion

dimethicone skin protectant

with soothing oat essence

To Protect & Relieve Dry Skin

12 fl oz (354 mL)

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

Use help prevent and temporarily protets chafed, chapped, or cracked skin.

Warnings For external use only.

When using this product avoid contact with eyes. In case of eye contact, flush with water.

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.

Directions  apply liberally as often as needed.

Other information Store at room temperature.

DISTRIBUTED BY: 

GREENBRIER INTERNATIONAL, INC.

500 VOLVO PARKWAY, CHESAPEAKE, VA 23320

MADE IN CHINA

Inactive Ingredients water, paraffinum liquidum, isopropyl myristate, glycerin, glyceryl stearate, propylene glycol, PEG-100 stearate, polyacrylamide, cetyl alcohol, avena sativa kernel extract, fragrance, DMDM hydantoin, stearyl alcohol, c13-14 isoparaffin, laureth-7, disodium EDTA, methylparaben, propylparaben.

label

DAILY MOISTURIZING - OATMEAL 
dimethicone lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:33992-0055
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE3 g  in 227 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
PETROLATUM (UNII: 4T6H12BN9U)  
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
GLYCERIN (UNII: PDC6A3C0OX)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
PEG-100 STEARATE (UNII: YD01N1999R)  
POLYACRYLAMIDE (1500 MW) (UNII: 5D6TC4BRWV)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
OAT (UNII: Z6J799EAJK)  
DMDM HYDANTOIN (UNII: BYR0546TOW)  
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
C13-14 ISOPARAFFIN (UNII: E4F12ROE70)  
LAURETH-7 (UNII: Z95S6G8201)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:33992-0055-2227 g in 1 BOTTLE; Type 0: Not a Combination Product05/19/2014
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34705/19/2014
Labeler - Greenbrier International (610322518)
Establishment
NameAddressID/FEIBusiness Operations
China Ningbo Shangge Cosmetic Technology Corp529287434manufacture(33992-0055)

Revised: 1/2019
Document Id: 808b7168-4952-600c-e053-2991aa0a3950
Set id: 568f8a23-39a1-48e7-a8a1-a25436c6cd71
Version: 2
Effective Time: 20190128
 
Greenbrier International