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

Active ingredients

White Petroleum 99.9%



Purpose skin protectant



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



Use

helps prevent diaper rash



Warnings

For external use only

When using this product do not get into eyes

See a doctor if condition worsens or lasts more than 7 days. Do not use on deep puncture wounds, animal bites, serious burns.



Directions

change and cleanse diaper area, and allow to dry

apply product as needed, with each diaper change, especially at bedtime and when exposure to wet diapers may be prolonged.



Inactive ingredients   fragrance

label

Personal Care

100% Pure Petroleum Jelly

Baby fresh scent

net wt. 3.52 oz (100 g)

Distributed by: Personal Care products, LLC

Troy, Michigan 48084 Made in India

PETROLEUM  
petrolatum jelly
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:29500-8040
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Petrolatum (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U) Petrolatum 99.9 g  in 100 g
Inactive Ingredients
Ingredient Name Strength
water (UNII: 059QF0KO0R)  
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:29500-8040-2 100 g in 1 CONTAINER
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part346 07/01/2012
Labeler - Personal Care Products (966155082)
Registrant - Personal Care Products (966155082)
Establishment
Name Address ID/FEI Business Operations
Jell Pharmaceuticals 726025211 manufacture(29500-8040)

Revised: 6/2012
Document Id: 4746fdd0-b393-491c-aaa1-9517c2ecf53c
Set id: 4481e3c6-67b7-42e0-9c0f-b97e0417e355
Version: 3
Effective Time: 20120628
 
Personal Care Products