Your browser does not support JavaScript! PETROLEUM (PETROLATUM) JELLY [PERSONAL CARE PRODUCTS]
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PETROLEUM (petrolatum) jelly
[Personal Care Products]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL OTC monograph final
NOTE: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.
Drug Label Sections

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 TypeHUMAN OTC DRUGItem Code (Source)NDC:29500-8040
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Petrolatum (PETROLATUM) Petrolatum99.9 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
water 
Packaging
#Item CodePackage Description
1NDC:29500-8040-2100 g in 1 CONTAINER
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(29500-8040)

Revised: 06/2012
Document Id: 4746fdd0-b393-491c-aaa1-9517c2ecf53c
Set id: 4481e3c6-67b7-42e0-9c0f-b97e0417e355
Version: 3
Effective Time: 20120628
 
Personal Care Products

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