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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White Petrolatum

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:

Principal Display Panel

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white_petrolatum

PETROLATUM 
petrolatum jelly
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67777-211
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:67777-211-01144 in 1 BOX
15 g in 1 PACKET
2NDC:67777-211-02425.2 g in 1 JAR
3NDC:67777-211-031 in 1 BOX
328.35 g in 1 TUBE
4NDC:67777-211-076 in 1 BOX
4113.4 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34701/31/2010
Labeler - Dynarex Corporation (008124539)
Registrant - Dynarex Corporation (008124539)
Establishment
NameAddressID/FEIBusiness Operations
Choice Laboratories650070394manufacture(67777-211)
Establishment
NameAddressID/FEIBusiness Operations
Jell Pharmaceuticals Pvt. Ltd.726025211manufacture(67777-211)

Revised: 4/2013
Document Id: 98f2d4bc-3a59-45d5-91c1-11833a06dc89
Set id: 7edfdec2-0d03-4226-b173-23a56f7d353c
Version: 14
Effective Time: 20130409
 
Dynarex Corporation