PERSONAL CARE PETROLEUM- petrolatum jelly 
PERSONAL CARE PRODUCTS

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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Personal Care Petroleum



Active Ingredients: White Petroleum 100%



Purpose skin protectant



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



Uses

temporarily protects minor cuts, scrapes, burns

temporarily protects and helps relieve chapped or cracked skin and lips


Warnings
For external use only
When using this product do not get into eyes
See a doctor if condition lasts  more than 7 days
Do not use on deep puncture wounds, animal bites, serious burns



Directions apply as needed



none

labelPersonal care

100% Pure Petroleum Jelly

Skin Protectant

Net Wet oz (170 g)

Distributed by:

Personal Care Products, LLC

Troy, Michigan 48084

Made in India

PERSONAL CARE PETROLEUM 
petrolatum jelly
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:29500-8010
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U) PETROLATUM170 g  in 170 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R) .1 g  in 170 g
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:29500-8010-2170 g in 1 JAR
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34607/01/2012
Labeler - PERSONAL CARE PRODUCTS (966155082)
Registrant - PERSONAL CARE PRODUCTS (966155082)
Establishment
NameAddressID/FEIBusiness Operations
JELL PHARMACEUTICALS726025211manufacture(29500-8010)

Revised: 6/2012
Document Id: 8af960fe-20ef-4f21-ac98-1d768e2b2665
Set id: 5eca3432-5c12-4567-a4ab-981f17ea04fa
Version: 3
Effective Time: 20120629
 
PERSONAL CARE PRODUCTS