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

Releif to rough, dry or chapped skin

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 Label

Back Label

Back 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:43749-720-13368 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: bb515eba-cda3-4f9d-bd2a-99a694dcd376
Set id: 41f11417-12c6-45ce-bb48-ddb105083562
Version: 2
Effective Time: 20180501
 
Unipack, Inc.