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NDC 45802-0143-03 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 Padagis Israel Pharmaceuticals Ltd. 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: 45802-0143-03
Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Neomycin, Polymyxin, and Bacitracin Topical

Product Information

NDC	45802-0143
Product ID	45802-143_dcf538de-596c-4411-9eb5-c27f40c5644c
Associated GPIs	90109803104200
GCN Sequence Number	061415
GCN Sequence Number Description	neomycin/bacitracin/polymyxinB OINT PACK 3.5-400-5K TOPICAL
HIC3	Q5W
HIC3 Description	TOPICAL ANTIBIOTICS
GCN	97206
HICL Sequence Number	033356
HICL Sequence Number Description	NEOMYCIN SULFATE/BACITRACIN ZINC/POLYMYXIN B
Brand/Generic	Brand
Proprietary Name	triple antibiotic
Proprietary Name Suffix	n/a
Non-Proprietary Name	bacitracin zinc, neomycin, polymyxin B
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	Padagis Israel Pharmaceuticals Ltd
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 45802-0143-03 (45802014303)

Pricing Information
NDC Package Code	45802-143-03
Billing NDC	45802014303
Package	1 TUBE in 1 CARTON (45802-143-03) / 28 g in 1 TUBE
Marketing Start Date	2014-05-20
NDC Exclude Flag	N
Price Per Unit	0.09463
Pricing Unit	GM
Effective Date	2024-02-21
NDC Description	TRIPLE ANTIBIOTIC OINTMENT
Pharmacy Type Indicator	C/I
OTC	Y
Explanation Code	1, 5
Classification for Rate Setting	G
As of Date	2024-02-21

This pricing file, entitled the NADAC (National Average Drug Acquisition Cost) files, provide state Medicaid agencies with covered outpatient drug prices by averaging survey invoice prices from retail community pharmacies across the United States. These pharmacies include independent retail community pharmacies and chain pharmacies. The prices are updated on a weekly and monthly basis

Standard Product Labeling (SPL)/Prescribing Information SPL 28fff253-ddd4-4669-aa90-b4caf48c905f Details

Active ingredients (in each gram)

Bacitracin zinc equivalent to 400 units bacitracin

Neomycin sulfate equivalent to 3.5 mg of neomycin base

Polymyxin B 5,000 units as polymyxin B sulfate

Purpose

First aid antibiotic

Use

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 1 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 right away. (1-800-222-1222)

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 20-25°C (68-77°F)

Inactive ingredients

cocoa butter, cottonseed oil, olive oil, sodium pyruvate, tocopheryl acetate, white petrolatum

Questions or comments?

1-800-719-9260

Principal Display Panel

Long Lasting Protection Against Infection

First Aid Antibiotic

#1 DOCTOR RECOMMENDED COMBINATION OF ACTIVE INGREDIENTS

Compare to Neosporin® active ingredients

Triple Antibiotic Ointment

Bacitracin Zinc, Neomycin Sulfate, Polymyxin B Sulfate

First Aid Antibiotic

NET WT 0.5 OZ (14 g)

Padagis™

Triple Antibiotic Ointment Carton Image 1

Triple Antibiotic Ointment Carton Image 2

INGREDIENTS AND APPEARANCE

TRIPLE ANTIBIOTIC

bacitracin zinc, neomycin, polymyxin b ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:45802-143
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
BACITRACIN ZINC (UNII: 89Y4M234ES) (BACITRACIN - UNII:58H6RWO52I)	BACITRACIN	400 [USP'U] 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 [USP'U] in 1 g

Ingredient Name	Strength
Inactive Ingredients
PETROLATUM (UNII: 4T6H12BN9U)
COCOA BUTTER (UNII: 512OYT1CRR)
COTTONSEED OIL (UNII: H3E878020N)
OLIVE OIL (UNII: 6UYK2W1W1E)
SODIUM PYRUVATE (UNII: POD38AIF08)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)

Product Characteristics
Color	WHITE (Translucent)	Score
Shape		Size
Flavor		Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:45802-143-01	1 in 1 CARTON	05/20/2014
1		14 g in 1 TUBE; Type 0: Not a Combination Product
2	NDC:45802-143-03	1 in 1 CARTON	05/20/2014
2		28 g in 1 TUBE; Type 0: Not a Combination Product
3	NDC:45802-143-70	144 in 1 CARTON	05/20/2014
3		.9 g in 1 PACKET; 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	05/20/2014

Labeler - Padagis Israel Pharmaceuticals Ltd (600093611)

Revised: 3/2022

Document Id: dcf538de-596c-4411-9eb5-c27f40c5644c

Set id: 28fff253-ddd4-4669-aa90-b4caf48c905f

Version: 6

Effective Time: 20220325