BACITRACIN ZINC, NEOMYCIN SULFATE AND POLYMYXIN B SULFATE ointment

bacitracin zinc, neomycin sulfate and polymyxin b sulfate by

Drug Labeling and Warnings

bacitracin zinc, neomycin sulfate and polymyxin b sulfate by is a Otc medication manufactured, distributed, or labeled by Kinray Inc., Dynarex Corporation, Galentic Pharma India Private Limited. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredient (in ea. gram)                                                Purpose
Bacitracin Zinc 400 Units                                                          First Aid Antibiotic

Neomyxin Sulfate 5mg (Equivalent to 3.5 mg Neomyxin)              First Aid Antibiotic

Polymyxin B Sulfate 5000 Units                                                 First Aid Antibiotic

Warnings:

For external use only

Dosage and Administration

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

Stop use and ask a doctor if

•  the condition persists or gets worse, or if a rash or other allergic reaction develops.

Indications and Usage

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

Keep out of reach of children

if swallowed, get medical help or contact a Poison Control Center right away

Purpose

First aid to help prevent infection in:
Minor cuts
scrapes
burns

Ask a doctor before use:

• in case of deep or puncture wounds
• animal bites
• serious burns
  

Other information

• store at controlled room temperature 15°-30° C (59°-86° F)
• avoid excessive heat and humidity

Inactive ingredients:

Hard Paraffin, Liquid Paraffin, White Soft Paraffin

Principal Display Panel

Triple Antibiotic Ointment:

triple_antibiotic.jpg

INGREDIENTS AND APPEARANCE

BACITRACIN ZINC, NEOMYCIN SULFATE AND POLYMYXIN B SULFATE 
bacitracin zinc, neomycin sulfate and polymyxin b sulfate ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63777-217
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BACITRACIN ZINC (UNII: 89Y4M234ES) (BACITRACIN - UNII:58H6RWO52I)	BACITRACIN	400 [iU]  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 [iU]  in 1 g

Inactive Ingredients
Ingredient Name	Strength
PETROLATUM (UNII: 4T6H12BN9U)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63777-217-01	28.35 g in 1 TUBE
2	NDC: 63777-217-02	14.17 g in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333B	04/15/2010

Labeler - Kinray Inc. (012574513)

Registrant - Dynarex Corporation (008124539)

Establishment
Name	Address	ID/FEI	Business Operations
Galentic Pharma India Private Limited		918531450	manufacture(63777-217)