Bacitracin Zinc, Neomycin Sulfate And Polymyxin B Sulfate Ointment [Kinray Inc.] -

BACITRACIN ZINC, NEOMYCIN SULFATE AND POLYMYXIN B SULFATE OINTMENT [KINRAY INC.]
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NDC	63777-217-01, 63777-217-02
Set ID	26898f51-a855-47e5-95d0-5ad9673b6236
Category	HUMAN OTC DRUG LABEL
Packager	Kinray Inc.
Generic Name
Product Class	Aminoglycoside Antibacterial
Product Number
Application Number	PART333

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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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

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

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

Labeler - Kinray Inc. (012574513)

Registrant - Dynarex Corporation (008124539)

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

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Medic