BUDPAK BACITRACIN- bacitracin zinc ointment

Budpak Bacitracin by

Drug Labeling and Warnings

Budpak Bacitracin 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 (each gram contains):

Bacitracin Zinc 500 units

PURPOSE

Purpose:

First aid antibiotic

INDICATIONS & USAGE

Uses:

First aid to help prevent infection in minor cuts, scrapes, and burns.

WARNINGS

Warnings:

For external use only.

DO NOT USE

Do not use:

In the eyes, if you are allergic to any of the ingredients, over large areas of the body, longer than 1 week unless directed by a doctor.

ASK DOCTOR

Ask a doctor before use:

In case of deep or puncture wounds, animal bites or serious burns

STOP USE

Stop use and ask a doctor if:

Condition persists or gets worse. Rash or other allergic reaction develops.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children:

If swallowed, get medical help or contact a Poison Control Center immediately.

DOSAGE & ADMINISTRATION

Directions:

Clean the affected area apply a small amount of this product (an amount equal to the surface area of the tip of a finger) on the area 1 to 3 times daily may be covered with a sterile bandage.

SPL UNCLASSIFIED SECTION

Other Information:

Store at 15ºC to 25ºC (59ºF to 77ºF). Lot No. & Exp. Date: See  box or crimp of tube.

INACTIVE INGREDIENT

Inactive Ingredients:

Hard Paraffin, Liquid Paraffin, White Soft Paraffin .

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL

Budpak Bacitracin Ointment

First Aid Antibiotic with Zinc

NET WT .5 OZ (14 g)

INGREDIENTS AND APPEARANCE

BUDPAK BACITRACIN 
bacitracin zinc ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 27293-035
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BACITRACIN ZINC (UNII: 89Y4M234ES) (BACITRACIN - UNII:58H6RWO52I)	BACITRACIN	500 [iU]  in 1 g

Inactive Ingredients
Ingredient Name	Strength
MINERAL OIL (UNII: T5L8T28FGP)
PARAFFIN (UNII: I9O0E3H2ZE)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 27293-035-14	14 g in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333B	03/30/2015

Labeler - Budpak Inc. (183224849)

Registrant - Anicare Pharmaceuticals Pvt. Ltd (916837425)

Establishment
Name	Address	ID/FEI	Business Operations
Anicare Pharmaceuticals Pvt. Ltd		916837425	manufacture(27293-035)