BUDPAK PETROLEUM COCOA BUTTER- white petrolatum jelly

Budpak Petroleum Cocoa Butter by

Drug Labeling and Warnings

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

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredient

White Petrolatum USP  99.9%

PURPOSE

Purpose

Skin Protectant

INDICATIONS & USAGE

Uses

Temporarily protects minor cuts, scrapes, 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

See a doctor if condition lasts 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 Poison Control Center right away.

DOSAGE & ADMINISTRATION

Directions

Apply as needed.

SPL UNCLASSIFIED SECTION

Other Information

Store at 20°to 25°C (68° to 77°F).

INACTIVE INGREDIENT

Inactive Ingredients

Theobroma Cacao (Cocoa) Seed Butter,  Fragrance.

SPL UNCLASSIFIED SECTION

PRINCIPAL DISPLAY PANEL

Budpak Petroleum Cocoa Butter Jelly

White Petrolatum 99.9%

NET WT 0.5 OZ (14 g)

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

BUDPAK PETROLEUM COCOA BUTTER 
white petrolatum jelly

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 27293-029
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U)	PETROLATUM	99.9 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
COCOA BUTTER (UNII: 512OYT1CRR)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 27293-029-14	1 in 1 BOX
1		14 g in 1 TUBE
2	NDC: 27293-029-28	1 in 1 BOX
2		28 g in 1 TUBE
3	NDC: 27293-029-35	1 in 1 BOX
3		35 g in 1 TUBE
4	NDC: 27293-029-42	1 in 1 BOX
4		42 g in 1 TUBE
5	NDC: 27293-029-02	1 in 1 BOX
5		113 g in 1 TUBE
6	NDC: 27293-029-03	1 in 1 BOX
6		226 g in 1 TUBE
7	NDC: 27293-029-04	453 g in 1 JAR

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part347	02/14/2014

Labeler - Budpak Inc. (183224849)

Registrant - Anicare Pharmaceuticals Pvt. Ltd (916837425)

Establishment
Name	Address	ID/FEI	Business Operations
Anicare Pharmaceuticals Pvt. Ltd		916837425	manufacture(27293-029)