TRIPLE ANTIBIOTIC- bacitracin zinc neomycin sulfate polymyxin b sulfate ointment

TRIPLE ANTIBIOTIC by

Drug Labeling and Warnings

TRIPLE ANTIBIOTIC by is a Otc medication manufactured, distributed, or labeled by Proficient Rx LP. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENTS

(in each gram)

Bacitracin zinc, USP 400 units

Neomycin sulfate, USP 3.5 mg

Polymyxin B sulfate, USP 5,000 units

PURPOSE

First aid antibiotic

USES

Helps prevent infection in

• minor cuts
• scrapes
• burns

WARNINGS

For external  use only

Allergy alert:

• do not use if allergic to any of the ingredients

DO NOT USE

• in the eyes
• over large areas of the body

ASK A DOCTOR BEFORE USE IF YOU HAVE

• deep or puncture wounds
• animal bites
• serious burns

WHEN USING THIS PRODUCT

• do not use longer than 1 week unless directed by a doctor

STOP USE AND ASK A DOCTOR IF

• 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 affected area
• apply a small 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 controlled room temperature 59º - 86ºF (15º - 30ºC).
• Protect from freezing.

INACTIVE INGREDIENT

White petrolatum

QUESTIONS?

1-800-432-8534 between 9 am and 4 pm EST, Monday – Friday.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC: 63187-039-01

Triple Antibiotic Ointment

FIRST AID ANTIBIOTIC

(Bacitracin Zinc-Neomycin Sulfate-Polymyxin B Sulfate Ointment)

First Aid to Help Prevent Infection in Minor Cuts, Scrapes and Burns

Compare to the active ingredients in Neosporin®*

NET WT 1 OZ (28 g)

*This product is not affiliated with, manufactured by, or produced by the makers of Neosporin®.

•   01791210G1 VC110203

Manufactured by: Actavis Mid Atlantic LLC

1877 Kawai Road, Lincolnton, NC 28092 USA

Relabeled by:

Proficient Rx LP

Thousand Oaks, CA 91320

INGREDIENTS AND APPEARANCE

TRIPLE ANTIBIOTIC 
bacitracin zinc neomycin sulfate polymyxin b sulfate ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63187-039(NDC:0472-0179)
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
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

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63187-039-15	14 g in 1 TUBE; Type 0: Not a Combination Product	05/01/2015
2	NDC: 63187-039-01	28 g in 1 TUBE; Type 0: Not a Combination Product	04/03/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333B	01/01/2003

Labeler - Proficient Rx LP (079196022)

Establishment
Name	Address	ID/FEI	Business Operations
Proficient Rx LP		079196022	RELABEL(63187-039)