Search by Drug Name or NDC

NDC 63187-0039-01 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 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: 63187-0039-01
Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Neomycin, Polymyxin, and Bacitracin Topical

Product Information

NDC	63187-0039
Product ID	63187-039_7af7836c-27c0-4fbf-82dc-3ccfafae12c4
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 63187-0039-01 (63187003901)

Pricing Information	N/A
NDC Package Code	63187-039-01
Billing NDC	63187003901
Package	28 g in 1 TUBE (63187-039-01)
Marketing Start Date	2017-04-03
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 45b1c4da-11ac-4e3a-8c77-0b0cdb78df24 Details

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

Distributed by:

Actavis Pharma, Inc.

Parsippany, NJ 07054 USA

Made in India

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

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

Labeler - Proficient Rx LP (079196022)

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

Revised: 4/2021

Document Id: 7af7836c-27c0-4fbf-82dc-3ccfafae12c4

Set id: 45b1c4da-11ac-4e3a-8c77-0b0cdb78df24

Version: 6

Effective Time: 20210401