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NDC 51672-2016-01 Triple Antibiotic 400; 3.5; 5000 [iU]/g; mg/g; [iU]/g Details

Triple Antibiotic 400; 3.5; 5000 [iU]/g; mg/g; [iU]/g

Triple Antibiotic is a TOPICAL OINTMENT in the HUMAN OTC DRUG category. It is labeled and distributed by Taro Pharmaceuticals U.S.A., Inc.. The primary component is BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE.

MedlinePlus Drug Summary

Neomycin, polymyxin, and bacitracin combination is used to prevent minor skin injuries such as cuts, scrapes, and burns from becoming infected. Neomycin, polymyxin, and bacitracin are in a class of medications called antibiotics. Neomycin, polymyxin, and bacitracin combination works by stopping the growth of bacteria.

Related Packages: 51672-2016-01
Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Neomycin, Polymyxin, and Bacitracin Topical

Product Information

NDC	51672-2016
Product ID	51672-2016_34f19b6e-8d34-4f3c-80ec-34d81ee6e044
Associated GPIs	90109803104200
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	Triple Antibiotic
Proprietary Name Suffix	n/a
Non-Proprietary Name	Bacitracin Zinc, Neomycin Sulfate, and Polymyxin B Sulfate
Product Type	HUMAN OTC DRUG
Dosage Form	OINTMENT
Route	TOPICAL
Active Ingredient Strength	400; 3.5; 5000
Active Ingredient Units	[iU]/g; mg/g; [iU]/g
Substance Name	BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE
Labeler Name	Taro Pharmaceuticals U.S.A., Inc.
Pharmaceutical Class	Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Decreased Cell Wall Synthesis & Repair [PE], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH FINAL
Application Number	part333B
Listing Certified Through	2024-12-31

Package

Package Images

NDC 51672-2016-01 (51672201601)

Pricing Information	N/A
NDC Package Code	51672-2016-1
Billing NDC	51672201601
Package	1 TUBE in 1 CARTON (51672-2016-1) / 14.2 g in 1 TUBE
Marketing Start Date	1995-12-14
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 33045ad1-a3b4-44a0-a50f-6754ed231f71 Details

SPL UNCLASSIFIED SECTION

Drug Facts

SPL UNCLASSIFIED SECTION

Active ingredients (in each gram)	Purpose
Bacitracin zinc USP 400 units	First aid antibiotic
Neomycin sulfate USP 3.5 mg	First aid antibiotic
Polymyxin B sulfate USP 5,000 units	First aid antibiotic

Uses

first aid to help prevent infection in minor:

cuts
scrapes
burns

Warnings

For external use only.

Do not use

in the eyes
over large areas of the body
if you are allergic to any of the ingredients

Ask a doctor before use if you have

deep or puncture wounds
animal bites
serious burns

Stop use and ask a doctor if

condition persists or gets worse
you need to use longer than 1 week
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 and dry thoroughly
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 20° to 25°C (68° to 77°F)
see carton or tube crimp for lot number and expiration date

Inactive ingredient

white petrolatum

Questions?

Call 1-866-923-4914

SPL UNCLASSIFIED SECTION

Distributed by:

Taro Pharmaceuticals U.S.A., Inc.

Hawthorne, NY 10532

PRINCIPAL DISPLAY PANEL - 28.4 g Tube Carton

Triple Antibiotic

Ointment

Original Strength

Bacitracin Zinc USP • Neomycin Sulfate USP • Polymyxin B Sulfate USP

First Aid Antibiotic Ointment

NET WT 1 oz (28.4 g)

Principal Display Panel - 28.4 g Tube Carton

INGREDIENTS AND APPEARANCE

TRIPLE ANTIBIOTIC

bacitracin zinc, neomycin sulfate, and polymyxin b sulfate ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:51672-2016
Route of Administration	TOPICAL

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

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

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:51672-2016-1	1 in 1 CARTON	12/14/1995
1		14.2 g in 1 TUBE; Type 0: Not a Combination Product
2	NDC:51672-2016-2	1 in 1 CARTON	12/14/1995
2		28.4 g in 1 TUBE; 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	12/14/1995

Labeler - Taro Pharmaceuticals U.S.A., Inc. (145186370)

Name	Address	ID/FEI	Business Operations
Establishment
Taro Pharmaceuticals Inc.		206263295	MANUFACTURE(51672-2016)

Revised: 1/2020

Document Id: 34f19b6e-8d34-4f3c-80ec-34d81ee6e044

Set id: 33045ad1-a3b4-44a0-a50f-6754ed231f71

Version: 3

Effective Time: 20200131

Search by Drug Name or NDC

NDC 51672-2016-01 Triple Antibiotic 400; 3.5; 5000 [iU]/g; mg/g; [iU]/g Details

Triple Antibiotic 400; 3.5; 5000 [iU]/g; mg/g; [iU]/g

MedlinePlus Drug Summary

Product Information

Package

Package Images

NDC 51672-2016-01 (51672201601)

Contents

Standard Product Labeling (SPL)/Prescribing Information SPL 33045ad1-a3b4-44a0-a50f-6754ed231f71 Details

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

Uses

Warnings

Do not use

Ask a doctor before use if you have

Stop use and ask a doctor if

Directions

Other information

Inactive ingredient

Questions?

SPL UNCLASSIFIED SECTION

PRINCIPAL DISPLAY PANEL - 28.4 g Tube Carton

INGREDIENTS AND APPEARANCE

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