First Aid Triple Antibiotic With Pain Reliever (Bacitracin Zinc, Neomycin Sulfate, Polymyxin B Sulfate, Lidocaine) Ointment [Cintas First Aid & Safety] -

FIRST AID TRIPLE ANTIBIOTIC WITH PAIN RELIEVER (BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, LIDOCAINE) OINTMENT [CINTAS FIRST AID & SAFETY]
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NDC	68421-6500-0
Set ID	fc0dc0be-1d9b-4ff0-ab48-b0fdd7b1cfce
Category	HUMAN OTC DRUG LABEL
Packager	Cintas First Aid & Safety
Generic Name
Product Class	Amide Local Anesthetic, Aminoglycoside Antibacterial, Antiarrhythmic
Product Number
Application Number	PART333B

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SPL UNCLASSIFIED SECTION

FIRST AID
TRIPLE ANTIBIOTIC
With PAIN RELIEVER
Active ingredients (in each gram)

Bacitracin zinc (400 units bacitracin

Neomycin sulfate (3.5 mg neomycin)

Polymyxin B sulfate (5000 units)

Lidocaine 40mg
Purpose

First Aid Antibiotic

First Aid Antibiotic

First Aid Antibiotic

Anesthetic
INDICATIONS & USAGE

Uses First aid to help prevent infection and provide temporary relief in minor cuts, scrapes and burns.
Warnings

For external use only
Do not use
- in eyes
- over large areas of the body
- in case of deep or puncture wounds, animal bites or serious burns
- if allergic to ingredients
- longer than 1 week unless directed by a doctor
STOP USE

Stop use and ask a doctor if condition gets worse or a rash or other allergic reactions occurs
KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children If ingested, contact a Poison Control Center right away.
Directions
- Adults and children 2yrs. And older: apply amount (equal to the surface area of a fingertip) on area 1 to 3 times daily, may cover with a sterile bandage
- Children under 2: Ask a Doctor
Inactive ingredients

petrolatum
PRINCIPLE DISPLAY PANEL

SUPER
BIOTIC
WOUND OINTMENT

#100210

FIRST AID
TRIPLE ANTIBIOTIC
WITH PAIN RELIEVER

0.7g (1/41 oz.)

Mfd for FAD
First Aid Direct
Mason, OH 45040

Active ingredients (in each gram)
Bacitracin zinc (400 units Bacitracin)
Neomycin sulfate (3.5 mg neomycin)
Polymyxin B sulfate (5000 units)
Lidocaine 40 mg

Purpose
First Aid Antibiotic
First Aid Antibiotic
First Aid Antibiotic
Anesthetic

Uses First aid to help prevent infection and provide temporary relief in minor cuts, scrapes, and burns

INGREDIENTS AND APPEARANCE

FIRST AID TRIPLE ANTIBIOTIC WITH PAIN RELIEVER
bacitracin zinc, neomycin sulfate, polymyxin b sulfate, lidocaine ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:68421-6500
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
bacitracin zinc (UNII: 89Y4M234ES) (bacitracin zinc - UNII:89Y4M234ES)	bacitracin zinc	400 [iU] in 1 g
neomycin sulfate (UNII: 057Y626693) (neomycin - UNII:I16QD7X297)	neomycin sulfate	3.5 mg in 1 g
polymyxin b sulfate (UNII: 19371312D4) (polymyxin b - UNII:J2VZ07J96K)	polymyxin b sulfate	5000 [iU] in 1 g
lidocaine (UNII: 98PI200987) (lidocaine - UNII:98PI200987)	lidocaine	40 mg in 1 g

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

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:68421-6500-0	0.7 g in 1 POUCH

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part333B	03/30/2007

Labeler - Cintas First Aid & Safety (056481716)

Registrant - Safetec of America, Inc. (874965262)

Name	Address	ID/FEI	Business Operations
Establishment
Safetec of America, Inc.		874965262	MANUFACTURE

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Medic

FIRST AID TRIPLE ANTIBIOTIC WITH PAIN RELIEVER (BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, LIDOCAINE) OINTMENT [CINTAS FIRST AID & SAFETY]

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