Triple Antibiotic (Bacitracin Zinc, Neomycin Sulfate, Polymyxin B Sulfate) Ointment [Provision Medical] -

TRIPLE ANTIBIOTIC (BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE) OINTMENT [PROVISION MEDICAL]
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NDC	69103-5005-1
Set ID	1cfd7b7b-a661-4889-b2a6-ab3ecf18f1f8
Category	HUMAN OTC DRUG LABEL
Packager	Provision Medical
Generic Name
Product Class	Aminoglycoside Antibacterial
Product Number
Application Number	PART333B

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Active ingredient

(in each gram)

Bacitracin zinc (400 units bacitracin)

Neomycin sulfate (3.5 mg neomycin)

Polymyxin B sulfate (5000 units)
Purpose

First Aid Antibiotic

First Aid Antibiotic

First Aid Antibiotic
Use

First aid to help prevent infection in minor cuts, scrapes, and burns.
Warnings
For external use only
Do not use
- in eyes
- over large areas of the body or on puncture wounds, animal bites or serious burns
- for more than 1 week unless directed by a doctor
- if you are allergic to any of the ingredients
Stop use and ask a doctor if
- a rash or allergic reaction develops
- condition worsens or persists
Keep out of reach of children

If ingested, contact a Poison Control Center right away.
Directions
- clean affected area
- apply a small amount 1 to 3 times daily
- may cover with a sterile bandage
Inactive ingredients

petrolatum
Principal Display Panel - 0.5g Packet Label

TAMPER EVIDENT. DO NOT USE IF PACKET IS TORN OR CUT.

ointment

Helps Prevent Infection in Cuts and Scrapes

TRIPLE ANTIBIOTIC

0.5g

The Provision First Aid LineTM

INGREDIENTS AND APPEARANCE

TRIPLE 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 [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
petrolatum (UNII: 4T6H12BN9U)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:69103-5005-1	0.5 g in 1 PACKET; 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	08/29/2014

Labeler - Provision Medical (036936831)

Registrant - Safetec of America, Inc. (874965262)

Name	Address	ID/FEI	Business Operations
Establishment
Safetec of America, Inc.		874965262	MANUFACTURE(69103-5005)

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Medic