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NDC 68001-0483-45 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 BluePoint Laboratories. 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: 68001-0483-45
Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Neomycin, Polymyxin, and Bacitracin Topical

Product Information

NDC	68001-0483
Product ID	68001-483_cd98812b-017d-2cd2-e053-2a95a90a38ce
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	Brand
Proprietary Name	Triple Antibiotic
Proprietary Name Suffix	n/a
Non-Proprietary Name	First Aid Antibiotic
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	BluePoint Laboratories
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 68001-0483-45 (68001048345)

Pricing Information
NDC Package Code	68001-483-45
Billing NDC	68001048345
Package	1 TUBE in 1 CARTON (68001-483-45) / 28.4 g in 1 TUBE
Marketing Start Date	2021-06-15
NDC Exclude Flag	N
Price Per Unit	0.11352
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 c47e15bd-1062-4cca-e053-2995a90a9075 Details

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredients

Bacitracin Zinc (400 units in each gram)

Neomycin Sulfate 5mg (equivalent to 3.5mg Neomycin per gram)

Polymyxin B Sulfate (5000 units per gram)

Purpose

First Aid Antibiotics

Uses

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

Warnings

For external use only.

Do not use

In the eyes or apply over large areas of the body
If you are allergic to any of the ingredients
Longer than 1 week unless directed by a doctor

SPL UNCLASSIFIED SECTION

Ask a doctor before use if you have deep or puncture wounds, animal bites, or serious burns

SPL UNCLASSIFIED SECTION

Stop use and ask a doctor if the condition persists or gets worse, or if a rash or other allergic reaction develops

SPL UNCLASSIFIED SECTION

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center 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

Do not use if seal on the tube is damaged or is not visible. To open, unscrew cap, pull tab to remove foil seal.
Store at room temperatue
Preserve in well-closed containers
See crimp of tube or carton for Lot Number and Expiry Date

Inactive ingredients

White Petrolatum

Questions?

Contact 1-800-707-4621

Manufactured in India by:

Gopaldas Visram & Company Limited.

Plot No. A327, T.T.C. Indl. Area, M.L.D.C.

Mahape, Navi Mumbai - 400710.

Mfg. Lic. No.: KD/503

For BluePoint Laboratories

Rev 09/2021

Package Label - Principal Display Panel

Triple Antibiotic Ointment 0.5 oz NDC: 68001-483-46

Triple Antibiotic Ointment 1 oz 68001-483-45

INGREDIENTS AND APPEARANCE

TRIPLE ANTIBIOTIC

first aid antibiotic ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:68001-483
Route of Administration	TOPICAL

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

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

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:68001-483-46	1 in 1 CARTON	06/15/2021
1		14.2 g in 1 TUBE; Type 0: Not a Combination Product
2	NDC:68001-483-45	1 in 1 CARTON	06/15/2021
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	06/15/2021

Labeler - BluePoint Laboratories (985523874)

Name	Address	ID/FEI	Business Operations
Establishment
Gopaldas Visram & Co Ltd		858030888	manufacture(68001-483)

Revised: 10/2021

Document Id: cd98812b-017d-2cd2-e053-2a95a90a38ce

Set id: c47e15bd-1062-4cca-e053-2995a90a9075

Version: 3

Effective Time: 20211005

Search by Drug Name or NDC

NDC 68001-0483-45 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 68001-0483-45 (68001048345)

Contents

Standard Product Labeling (SPL)/Prescribing Information SPL c47e15bd-1062-4cca-e053-2995a90a9075 Details

SPL UNCLASSIFIED SECTION

Active ingredients

Purpose

Uses

Warnings

Do not use

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

Directions

Other information

Inactive ingredients

Questions?

Package Label - Principal Display Panel

INGREDIENTS AND APPEARANCE

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