BUDPAK TRIPLE ANTIBIOTIC MAXIMUM STRENGTH- bacitracin zinc, neomycin sulfate and polymyxin b sulfate ointment

Budpak Triple Antibiotic Maximum Strength by

Drug Labeling and Warnings

Budpak Triple Antibiotic Maximum Strength 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 Ingredients

Bacitracin Zinc 400U

Neomycin 3.5 mg

Polymyxin B Sulfate 5000U

PURPOSE

Purpose

First Aid Antibiotic

INDICATIONS & USAGE

Uses

first aid to help prevent infection in

• minor cuts
• scrapes
• 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
• longer than 1 week unless directed by a doctor
• over large areas of the body

ASK DOCTOR

Ask a doctor before use on

• on deep puncture wounds, animal bites, or serious burns

STOP USE

Stop use and consult a doctor if the condition persists or gets worse, or if a 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 right away.

DOSAGE & ADMINISTRATION

Directions

• Clean the affected area and dry thoroughly
• 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 room temperature 20°C to 25°C (68°F to 77°C)
• Lot No. Exp. Date: see crimp of tube

INACTIVE INGREDIENT

Inactive Ingredients

Cocoa butter, Petrolatum, Cottonseed oil, Olive oil, Tocopheryl acetate, Sodium pyruvate.

SPL UNCLASSIFIED SECTION

PRINCIPAL DISPLAY PANEL

Budpak Triple Antibiotic

First Aid Antibiotic Ointment

NET WT 0.5 OZ (14 g)

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

BUDPAK TRIPLE ANTIBIOTIC MAXIMUM STRENGTH 
bacitracin zinc, neomycin sulfate and polymyxin b sulfate ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 27293-024
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BACITRACIN ZINC (UNII: 89Y4M234ES) (BACITRACIN - UNII:58H6RWO52I)	BACITRACIN	400 [USP'U]  in 1 g
NEOMYCIN SULFATE (UNII: 057Y626693) (NEOMYCIN - UNII:I16QD7X297)	NEOMYCIN	3.5 mg  in 1 g
POLYMYXIN B SULFATE (UNII: 19371312D4) (POLYMYXIN B - UNII:J2VZ07J96K)	POLYMYXIN B	5000 [USP'U]  in 1 g

Inactive Ingredients
Ingredient Name	Strength
COCOA BUTTER (UNII: 512OYT1CRR)
PETROLATUM (UNII: 4T6H12BN9U)
COTTONSEED OIL (UNII: H3E878020N)
OLIVE OIL (UNII: 6UYK2W1W1E)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
SODIUM PYRUVATE (UNII: POD38AIF08)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 27293-024-01	1 in 1 BOX
1	NDC: 27293-024-14	14 g in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333B	06/10/2013

Labeler - Budpak Inc. (183224849)

Registrant - Anicare Pharmaceuticals Pvt. Ltd (916837425)

Establishment
Name	Address	ID/FEI	Business Operations
Anicare Pharmaceuticals Pvt. Ltd		916837425	manufacture(27293-024)