PETROLATUM- petrolatum jelly 
Choice Laboratories Limited

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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Petrolatum Jelly

Active Ingredient                            Purpose

White Petrolatum 100%                 Skin Protectant            

Uses:

Warnings:

For external use only.

When using this product:

Do not get in eyes.

Stop use and ask a doctor if:

Do not use on:

Keep out of reach of children

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

Directions:

Other information:

Indications and Usage

Skin Protectant

Principal Display Panel

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Petrolatum

PETROLATUM 
petrolatum jelly
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63174-211
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U) PETROLATUM1 g  in 1 g
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:63174-211-07113.4 g in 1 TUBE; Type 0: Not a Combination Product
2NDC:63174-211-0328.35 g in 1 TUBE; Type 0: Not a Combination Product
3NDC:63174-211-02425.2 g in 1 JAR; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34705/18/2015
Labeler - Choice Laboratories Limited (650070394)
Establishment
NameAddressID/FEIBusiness Operations
Choice Laboratories Limted650070394manufacture(63174-211)

Revised: 5/2015
Document Id: 0e835741-1f5d-4418-b9fb-974baaef54c0
Set id: b772049b-c5a4-4670-a29e-c7187ed23251
Version: 1
Effective Time: 20150518
 
Choice Laboratories Limited