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.

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Drug Facts


Active Ingredient                                          Purpose

Dimethicone 0.15%                                      Skin Protectant



Help prevent and temporarily protects chafed, chapped or cracked skin.
Helps prevent and protect from the drying effects of wind and cold weather.



If swallowed, get medical help or contact a Poison Control Center right away.

Apply as needed, and do not get into 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.

apply as needed

water, mineral oil, cetyl alcohol, glycerin, propylene glycol, methylparaben, propylparaben, DMDM hydantoin, steareth-30, ammonium polyacrylate,  C13-16 isoparaffin, glyceryl stearate, fragrance, avena sativa (oat) protein extract

image of OTC
OATMEAL 
dimethicone lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:33992-1129
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
dimethicone (UNII: 92RU3N3Y1O) (dimethicone - UNII:92RU3N3Y1O) dimethicone0.15 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
water (UNII: 059QF0KO0R)  
mineral oil (UNII: T5L8T28FGP)  
cetyl alcohol (UNII: 936JST6JCN)  
petrolatum (UNII: 4T6H12BN9U)  
glycerin (UNII: PDC6A3C0OX)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
dmdm hydantoin (UNII: BYR0546TOW)  
propylparaben (UNII: Z8IX2SC1OH)  
methylparaben (UNII: A2I8C7HI9T)  
steareth-30 (UNII: 5776GCL1DG)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:33992-1129-1340.2 g in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34712/06/2011
Labeler - GREENBRIER INTERNATIONAL (610322518)
Registrant - NINGBO PULISI DAILY CHEMICAL PRODUCTS CO., LTD. (529047265)
Establishment
NameAddressID/FEIBusiness Operations
NINGBO PULISI DAILY CHEMICAL PRODUCTS CO., LTD. 529047265manufacture

Revised: 12/2011
Document Id: beca4704-56ec-4d40-8daf-fc4d96a29e10
Set id: 42fd9acd-2922-4b84-abcb-446498f5e6f0
Version: 1
Effective Time: 20111206
 
GREENBRIER INTERNATIONAL