COCOA BUTTER - petrolatum  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

Petrolatum 5%                                      Skin Protectant



Skin Protectant

Keep out of reach of children

Use daily, do not use around eye area

For external use only, Do not use around the eye area.Stop use and ask a doctor if redness or imitation develop and persist for more than 7 days

apply as needed

water, mineral oil, cetyl alcohol, glyceryl stearate, glycerin, dimethicone, propylene glycol, methylparaben, propylparaben, DMDM hydantoin, ammonium polyacrylate, steareth-30, tocopheryl acetate, cocoa butter, shea butter extract, fragrance, blue 1, red 33, yellow 5, yellow 6  


image of bottle label

COCOA BUTTER 
petrolatum lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:33992-1108
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
petrolatum (UNII: 4T6H12BN9U) (petrolatum - UNII:4T6H12BN9U) petrolatum 5 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
water (UNII: 059QF0KO0R)  
mineral oil (UNII: T5L8T28FGP)  
cetyl alcohol (UNII: 936JST6JCN)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
glycerin (UNII: PDC6A3C0OX)  
dimethicone (UNII: 92RU3N3Y1O)  
propylene glycol (UNII: 6DC9Q167V3)  
methylparaben (UNII: A2I8C7HI9T)  
propylparaben (UNII: Z8IX2SC1OH)  
steareth-30 (UNII: 5776GCL1DG)  
cocoa butter (UNII: 512OYT1CRR)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:33992-1108-1396.9 g in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34708/02/2011
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: 8/2011
Document Id: abe4d54d-b026-45d0-beda-2f36ffa0c4bd
Set id: 577d47c9-4a40-4994-9b62-974166375183
Version: 1
Effective Time: 20110802
 
GREENBRIER INTERNATIONAL