PETROLEUM JELLY- white petrolatum jelly 
Unipack, 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 (100%)

Purpose

Skin Protectant

Uses

temporarily protects minor: cuts, scrapes, burns.  temporarily protects and helps relieve chapped or cracked skin and lips.  helps protect from the drying effects of wind and cold weather

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 or puncture wounds, animal bites, serious burns.

Keep out of reach of children

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Apply as needed

Front Label

Front LabelFront Label

Back Label

Back LabelBack Label

PETROLEUM JELLY 
white petrolatum jelly
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43749-720
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U) PETROLATUM100 g  in 100 g
Product Characteristics
ColorwhiteScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:43749-720-04113 g in 1 JAR; Type 0: Not a Combination Product12/10/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34712/10/2017
Labeler - Unipack, Inc. (009248480)
Establishment
NameAddressID/FEIBusiness Operations
Unipack, Inc.009248480manufacture(43749-720)

Revised: 5/2018
Document Id: dec31c08-5821-44e1-abe4-fa5e5a593e96
Set id: 6442a79c-65c1-422e-b68c-53ce4edf86cc
Version: 3
Effective Time: 20180503
 
Unipack, Inc.