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NDC 71205-0600-28 Triple Antibiotic 400; 3.5; 5000 [USP'U]/g; mg/g; [USP'U]/g Details

Triple Antibiotic 400; 3.5; 5000 [USP'U]/g; mg/g; [USP'U]/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: 71205-0600-28
Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Neomycin, Polymyxin, and Bacitracin Topical

Product Information

NDC	71205-0600
Product ID	71205-600_c4ab8ed6-6890-4f43-81a3-fad27fb89cad
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, and Polymyxin B sulfate
Product Type	HUMAN OTC DRUG
Dosage Form	OINTMENT
Route	TOPICAL
Active Ingredient Strength	400; 3.5; 5000
Active Ingredient Units	[USP'U]/g; mg/g; [USP'U]/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 71205-0600-28 (71205060028)

Pricing Information	N/A
NDC Package Code	71205-600-28
Billing NDC	71205060028
Package	1 TUBE in 1 CARTON (71205-600-28) / 28 g in 1 TUBE
Marketing Start Date	2021-08-18
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL c4ab8ed6-6890-4f43-81a3-fad27fb89cad Details

SPL UNCLASSIFIED SECTION

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.

Do not use

•: if you are allergic to any of the ingredients
•: 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

Stop use and ask a doctor if

•: you need to use longer than one week
•: condition persists or gets worse
•: rash or other allergic reaction develops

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

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

Other information

•: store at 15°-30°C (59°-86°F). Protect from freezing.
•: before using any medication, read all label directions. Keep carton, it contains important information.

Inactive ingredient

white petrolatum

Questions or comments?

Call 1-877-753-3935 Monday-Friday 9AM-5PM EST

SPL UNCLASSIFIED SECTION

Distributed by: H2-Pharma, LLC

Montgomery, AL 36117

Relabeled by: Proficient Rx LP

Thousand Oaks, CA 91320

PRINCIPAL DISPLAY PANEL - 28 g Tube Carton

NDC 71205-600-28

*Compare to the active ingredients in

Neosporin® Original Ointment

Triple Antibiotic Ointment

Bacitracin zinc | Neomycin sulfate | Polymyxin B sulfate Ointment

First aid antibiotic

For external use only

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

Net wt. 1 oz (28 g)

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:71205-600(NDC:61269-179)
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
BACITRACIN ZINC (UNII: 89Y4M234ES) (BACITRACIN - UNII:58H6RWO52I)	BACITRACIN ZINC	400 [USP'U] in 1 g
NEOMYCIN SULFATE (UNII: 057Y626693) (NEOMYCIN - UNII:I16QD7X297)	NEOMYCIN SULFATE	3.5 mg in 1 g
POLYMYXIN B SULFATE (UNII: 19371312D4) (POLYMYXIN B - UNII:J2VZ07J96K)	POLYMYXIN B	5000 [USP'U] in 1 g

Ingredient Name	Strength
Inactive Ingredients
WHITE PETROLATUM (UNII: B6E5W8RQJ4)

Product Characteristics
Color	YELLOW (light yellow)	Score
Shape		Size
Flavor		Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:71205-600-28	1 in 1 CARTON	08/18/2021
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	05/24/2021

Labeler - Proficient Rx LP (079196022)

Name	Address	ID/FEI	Business Operations
Establishment
Proficient Rx LP		079196022	RELABEL(71205-600)

Revised: 8/2021

Document Id: c4ab8ed6-6890-4f43-81a3-fad27fb89cad

Set id: c4ab8ed6-6890-4f43-81a3-fad27fb89cad

Version: 1

Effective Time: 20210801

Search by Drug Name or NDC

NDC 71205-0600-28 Triple Antibiotic 400; 3.5; 5000 [USP'U]/g; mg/g; [USP'U]/g Details

Triple Antibiotic 400; 3.5; 5000 [USP'U]/g; mg/g; [USP'U]/g

MedlinePlus Drug Summary

Product Information

Package

Package Images

NDC 71205-0600-28 (71205060028)

Contents

Standard Product Labeling (SPL)/Prescribing Information SPL c4ab8ed6-6890-4f43-81a3-fad27fb89cad Details

SPL UNCLASSIFIED SECTION

Active ingredients (in each gram)

Purpose

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 or comments?

SPL UNCLASSIFIED SECTION

PRINCIPAL DISPLAY PANEL - 28 g Tube Carton

INGREDIENTS AND APPEARANCE

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