COCOA BUTTER- petrolatum lotion

Cocoa Butter by

Drug Labeling and Warnings

Cocoa Butter by is a Otc medication manufactured, distributed, or labeled by GREENBRIER INTERNATIONAL, NINGBO PULISI DAILY CHEMICAL PRODUCTS CO., LTD. . Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredient                                     Purpose

Petrolatum 5%                                      Skin Protectant

PURPOSE

Skin Protectant

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children

INDICATIONS & USAGE

Use daily, do not use around eye area

WARNINGS

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

DOSAGE & ADMINISTRATION

apply as needed

INACTIVE INGREDIENT

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  

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

COCOA BUTTER 
petrolatum lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 33992-1108
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
petrolatum (UNII: 4T6H12BN9U) (petrolatum - UNII:4T6H12BN9U)	petrolatum	5 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 33992-1108-1	396.9 g in 1 BOTTLE, PLASTIC

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part347	08/02/2011

Labeler - GREENBRIER INTERNATIONAL (610322518)

Registrant - NINGBO PULISI DAILY CHEMICAL PRODUCTS CO., LTD. (529047265)

Establishment
Name	Address	ID/FEI	Business Operations
NINGBO PULISI DAILY CHEMICAL PRODUCTS CO., LTD.		529047265	manufacture