BUDPAK PETROLEUM- petroleum jelly 
Budpak 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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BUDPAK PETROLEUM JELLY

Active Ingredient

White Petrolatum USP (100%)

Purpose

Skin Protectant

Uses

Warnings

For external use only.

When using this product do not get into eyes.

Stop use and ask a doctor if

• conditions last more than 7 days.

Do not use on

Keep out of reach of children

Directions

Apply as needed.

Inactive Ingredients

None

PRINCIPAL DISPLAY PANEL

BUDPAK PETROLEUM JELLY

NET WT. 8 OZ. (226g)

PRINCIPAL DISPLAY PANEL

BUDPAK PETROLEUM 
petroleum jelly
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:27293-033
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U) PETROLATUM100 g  in 100 g
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:27293-033-06113 g in 1 BOTTLE
2NDC:27293-033-13170 g in 1 BOTTLE
3NDC:27293-033-12226 g in 1 BOTTLE
4NDC:27293-033-07283 g in 1 BOTTLE
5NDC:27293-033-11368 g in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34707/07/2014
Labeler - Budpak Inc. (183224849)
Registrant - Jell Pharmaceuticals Pvt. Ltd. (726025211)
Establishment
NameAddressID/FEIBusiness Operations
Jell Pharmaceuticals Pvt. Ltd.726025211manufacture(27293-033)

Revised: 7/2014
Document Id: 838d36cc-e9c2-407c-ad94-e8c1cf482ebe
Set id: df33b4b5-e4ce-476c-a151-fc81ce266c1a
Version: 1
Effective Time: 20140707
 
Budpak Inc.