PETROLATUM - petrolatum jelly 
Dynarex Corporation

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:

Petrolatum Jelly

Petrolatum_Jelly.jpg

PETROLATUM 
petrolatum jelly
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67777-400
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:67777-400-0112 in 1 CASE
16 in 1 BOX
1113.4 g in 1 TUBE
2NDC:67777-400-0212 in 1 CASE
26 in 1 BOX
228.35 g in 1 TUBE
3NDC:67777-400-0312 in 1 CASE
36 in 1 BOX
358.7 g in 1 TUBE
4NDC:67777-400-0412 in 1 CASE
4425.2 g in 1 JAR
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34703/23/2010
Labeler - Dynarex Corporation (008124539)
Registrant - Dynarex Corporation (008124539)
Establishment
NameAddressID/FEIBusiness Operations
Galentic PharmaIndia Private Limited918531450manufacture(67777-400)
Establishment
NameAddressID/FEIBusiness Operations
Amar Remedies Limited915839811manufacture(67777-400)

Revised: 12/2012
Document Id: b582c7fd-fb35-42a1-a897-3bb219d19851
Set id: dfc69165-44a8-4d5e-bfeb-6f2d8d207e16
Version: 7
Effective Time: 20121213
 
Dynarex Corporation