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Package Insert and Label Information: Triple Antibiotic

By Tiger Medical Group (US), Inc. | Last revised: 1 January 2012

TRIPLE ANTIBIOTIC — bacitracin, neomycin sulfate and polymyxin b sulfate ointment
Tiger Medical Group (US), Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Active Ingredients (In each gram)

Bacitracin 400 Units, Neomycin Sulfate 3.5 mg, Polymyxin B Sulfate 5,000 Units

Use

First aid to help prevent infection in minor cuts, scrapes, and burns.

Warnings

For external use only.

Purpose

First aid antibiotic

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.

KEEP OUT OF REACH OF CHILDREN. In case of accidental ingestion, contact a Poison Control Center right away.

Do not use

In the eyes or apply over large areas of the body.

In case of deep or puncture wounds, animal bites or serious burns, consult a doctor.

If you are allergic to any of the ingredients.

Longer than 1 week unless directed by a doctor.

Stop use and consult a doctor

if condition persists or gets worse, or if a rash or other allergic reaction develops.

Inactive Ingredients

White petrolatum

NET WT. 1oz.(28 g)

box label
(click image for full-size original)

TRIPLE ANTIBIOTIC
neomycin sulfate ointment
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:75934-0004
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Bacitracin (Bacitracin) Bacitracin 400 [iU] in 1 g
Neomycin Sulfate (Neomycin) Neomycin Sulfate 3.5 mg in 1 g
Polymyxin B Sulfate (Polymyxin B) Polymyxin B Sulfate 5000 [iU] in 1 g
Inactive Ingredients
Ingredient Name Strength
PETROLATUM
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:75934-0004-2 0.9 g in 1 PACKAGE None
2 NDC:75934-0004-1 12 TUBE (TUBE) in 1 BOX contains a TUBE
2 28 g in 1 TUBE This package is contained within the BOX (75934-0004-1)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part333B 01/01/2012
Labeler — Tiger Medical Group (US), Inc. (544980548)

Revised: 01/2012 Tiger Medical Group (US), Inc.