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NDC 71205-0006-28 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 Proficient Rx LP. 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: 71205-0006-28
Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Neomycin, Polymyxin, and Bacitracin Topical

Product Information

NDC	71205-0006
Product ID	71205-006_781660f1-432b-4f46-9ee3-8c735e5a8bea
Associated GPIs	90109803104200
GCN Sequence Number	007694
GCN Sequence Number Description	neomycin/bacitracin/polymyxinB OINT. (G) 3.5-400-5K TOPICAL
HIC3	Q5W
HIC3 Description	TOPICAL ANTIBIOTICS
GCN	85459
HICL Sequence Number	033356
HICL Sequence Number Description	NEOMYCIN SULFATE/BACITRACIN ZINC/POLYMYXIN B
Brand/Generic	Generic
Proprietary Name	TRIPLE ANTIBIOTIC
Proprietary Name Suffix	n/a
Non-Proprietary Name	Bacitracin Zinc Neomycin Sulfate 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	Proficient Rx LP
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 71205-0006-28 (71205000628)

Pricing Information	N/A
NDC Package Code	71205-006-28
Billing NDC	71205000628
Package	1 TUBE in 1 CARTON (71205-006-28) / 28 g in 1 TUBE
Marketing Start Date	2018-04-02
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 949c5b44-ee52-4913-8872-39181d319998 Details

Drug Facts

Active ingredients (in each gram)

Bacitracin zinc, USP 400 units

Neomycin 3.5 mg

Polymyxin B sulfate, USP 5,000 units

Purpose

First aid antibiotic

Uses

First aid to help 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 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 controlled room temperature 59°-86°F (15°-30°C). Protect from freezing.
•: Before using any medication, read all label directions. Keep carton, it contains important information.

Inactive ingredient

white petrolatum

Questions?

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

Principal Display Panel

Distributed by:

MAJOR® PHARMACEUTICALS

Livonia, MI 48152

Product of India

Relabeled by:

Proficient Rx LP

Thousand Oaks, CA 91320

Protection Against Infection

NDC 71205-006-28

ORIGINAL STRENGTH

TRIPLE ANTIBIOTIC OINTMENT

Bacitracin Zinc–Neomycin Sulfate–Polymyxin B Sulfate

FIRST AID ANTIBIOTIC

Compare to the Active Ingredients in Neosporin®*

NET WT 1 oz (28g)

INGREDIENTS AND APPEARANCE

TRIPLE ANTIBIOTIC

bacitracin zinc neomycin sulfate polymyxin b sulfate ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:71205-006(NDC:0904-0734)
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:71205-006-28	1 in 1 CARTON	04/02/2018
1		28 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	06/01/2011

Labeler - Proficient Rx LP (079196022)

Name	Address	ID/FEI	Business Operations
Establishment
Proficient Rx LP		079196022	RELABEL(71205-006)

Revised: 7/2022

Document Id: 781660f1-432b-4f46-9ee3-8c735e5a8bea

Set id: 949c5b44-ee52-4913-8872-39181d319998

Version: 5

Effective Time: 20220701