BUDPAK PETROLEUM- petroleum jelly

Budpak Petroleum by

Drug Labeling and Warnings

Budpak Petroleum by is a Otc medication manufactured, distributed, or labeled by Budpak Inc., Jell Pharmaceuticals Pvt. Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredient

White Petrolatum USP (100%)

PURPOSE

Purpose

Skin Protectant

INDICATIONS & USAGE

Uses

• Temporarily protects minor cuts, scrapes or burns.

• Temporarily protects and helps relieve chapped or cracked skin and lips.

• Helps protect from the drying effects of wind and cold weather.

WARNINGS

Warnings

For external use only.

WHEN USING

When using this product do not get into eyes.

STOP USE

Stop use and ask a doctor if

conditions last more than 7 days.

DO NOT USE

Do not use on

• deep or puncture wounds
• animal bites
• serious burns

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children

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

DOSAGE & ADMINISTRATION

Directions

Apply as needed.

INACTIVE INGREDIENT

Inactive Ingredients

None

SPL UNCLASSIFIED SECTION

PRINCIPAL DISPLAY PANEL

BUDPAK PETROLEUM JELLY

NET WT. 8 OZ. (226g)

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

BUDPAK PETROLEUM 
petroleum jelly

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 27293-033
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U)	PETROLATUM	100 g  in 100 g

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 27293-033-06	113 g in 1 BOTTLE
2	NDC: 27293-033-13	170 g in 1 BOTTLE
3	NDC: 27293-033-12	226 g in 1 BOTTLE
4	NDC: 27293-033-07	283 g in 1 BOTTLE
5	NDC: 27293-033-11	368 g in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part347	07/07/2014

Labeler - Budpak Inc. (183224849)

Registrant - Jell Pharmaceuticals Pvt. Ltd. (726025211)

Establishment
Name	Address	ID/FEI	Business Operations
Jell Pharmaceuticals Pvt. Ltd.		726025211	manufacture(27293-033)