Triple Antibiotic (Bacitracin Zinc, Neomycin Sulfate, Polymyxin B) Ointment [Kareway Product, Inc.] -

TRIPLE ANTIBIOTIC (BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B) OINTMENT [KAREWAY PRODUCT, INC.]
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NDC	67510-0631-1
Set ID	b249ea8c-5418-4189-a39b-ce0174fa60c6
Category	HUMAN OTC DRUG LABEL
Packager	Kareway Product, Inc.
Generic Name
Product Class	Aminoglycoside Antibacterial
Product Number
Application Number	PART333B

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Active ingredient

Bacitracin Zinc 400 units

Neomycin Sulfate 3.5mg

Polymyxin B Sulfate 5,000 units
Purpose

First aid antibiotic

First aid antibiotic

First aid antibiotic
Uses
First aid to help prevent infection in minor:
- cuts
- scrapes
- burns
Warnings
For external use only.
Do not use
- If you are allergic to any of the ingredients
When using this product
- do not use in the eyes
- do not apply over large areas of the body
Stop use and ask a doctor if
- you need to use longer than 1 week
- condition persists or gets worse
- rash or other allergic reaction develops
Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.
Directions
- adults and children 2 years of age and older:
- - 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
- children under 2 years of age: ask a doctor
Other information
- store at 15° to 25°C (59° to 77°F)
Inactive ingredients

cetyl alcohol, mineral oil, petrolatum, squalane, stearic acid, tocopheryl acetate
Package label panel

Triple Antibiotic Ointment

INGREDIENTS AND APPEARANCE

TRIPLE ANTIBIOTIC
bacitracin zinc, neomycin sulfate, polymyxin b ointment

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
CETYL ALCOHOL (UNII: 936JST6JCN)
MINERAL OIL (UNII: T5L8T28FGP)
SQUALANE (UNII: GW89575KF9)
STEARIC ACID (UNII: 4ELV7Z65AP)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
PETROLATUM (UNII: 4T6H12BN9U)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:67510-0631-1	1 in 1 BOX	12/12/2013
1		28.3 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part333B	12/12/2013

Labeler - Kareway Product, Inc. (121840057)

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Medic