First Aid Antibiotic (Bacitracin Zinc, Neomycin Sulfate, Polymyxin B Sulfate) Ointment [Gfa Production (Xiamen) Co., Ltd.] -

FIRST AID ANTIBIOTIC (BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE) OINTMENT [GFA PRODUCTION (XIAMEN) CO., LTD.]
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NDC	50814-007-01
Set ID	9f970b62-310b-42a4-883a-43641ccb8516
Category	HUMAN OTC DRUG LABEL
Packager	GFA Production (Xiamen) Co., Ltd.
Generic Name
Product Class	Aminoglycoside Antibacterial
Product Number
Application Number	PART333B

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Drug Facts
Active ingredients (in each gram)

Bacitracin zinc (bacitracin 400 units)

Neomycin sulfate (neomycin 3.5 mg)

Polymyxin B sulfate (polymyxin B 5,000 units)

Purpose

First aid antibiotic
Use
- First aid to help prevent infection in minor cuts, scrapes, and burns.
Warnings

For external use only.

Do not use

• Do not use • in the eyes • over large areas of the body • if you are allergic to any of the ingredients

• longer than 1 week unless directed by a doctor.

Ask a doctor before use if you have

• deep or puncture wounds • animal bites • serious burns.

Stop use and ask a doctor if

• the condition persists or gets worse • a 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

• 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.
Other information

Store at room temperature
Inactive ingredients

Mineral Oil, petrolatum, purified water
Package Labeling:

INGREDIENTS AND APPEARANCE

FIRST AID ANTIBIOTIC
bacitracin zinc, neomycin sulfate, 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

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:50814-007-01	0.9 g in 1 BAG; Type 0: Not a Combination Product	07/01/2016

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part333B	07/01/2016

Labeler - GFA Production (Xiamen) Co., Ltd. (421256261)

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