CAREALL CREAMY COCOA BUTTER PETROLEUM JELLY- petrolatum cream 
New World Imports, Inc

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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Active Ingredient

White Petrolatum USP

Purpose

Skin Protectant

Uses

Warnings

For external use only. Do not use on deep puncture wounds, animal bites and serious burns.

When using this product, do not get into eyes.

Stop use and ask a doctor if:

•condition worsens

•symptoms last more than 7 days

•clear up and occur again within a few days

Keep out of reach of Children

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

Directions

apply as needed.

Inactive Ingredients

water (aqua), glycerin, glyceryl monostearate, PEG—100 stearate, stearic acid, ceteareth 20, triethanolamine, lanolin alcohol, fragrance, acrylates/C 10-30 alkyl acrylate crosspolymer, phenoxyethanol, triethylene glycol, cocoa butter, tocopheryl acetate, disodium EDTA

51824-083-03 Cocoa PJ

CAREALL CREAMY COCOA BUTTER PETROLEUM JELLY 
petrolatum cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51824-083
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U) PETROLATUM30 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
GLYCERIN (UNII: PDC6A3C0OX)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
PEG-100 STEARATE (UNII: YD01N1999R)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)  
TROLAMINE (UNII: 9O3K93S3TK)  
LANOLIN ALCOHOLS (UNII: 884C3FA9HE)  
CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 71DD5V995L)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
TRIETHYLENE GLYCOL (UNII: 3P5SU53360)  
COCOA BUTTER (UNII: 512OYT1CRR)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
Product Characteristics
ColorwhiteScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:51824-083-0385 g in 1 TUBE; Type 0: Not a Combination Product02/01/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34702/01/2021
Labeler - New World Imports, Inc (075372276)

Revised: 12/2020
Document Id: bf2119f8-4566-461b-b284-97cafa63419e
Set id: 9358b8ef-df14-45fc-9bfd-9052577a1f88
Version: 1
Effective Time: 20201231
 
New World Imports, Inc