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NDC 69396-0062-09 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 Trifecta Pharmaceuticals USA LLC. 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: 69396-0062-09
Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Neomycin, Polymyxin, and Bacitracin Topical

Product Information

NDC	69396-0062
Product ID	69396-062_d57ad01b-76dc-58e3-e053-2a95a90a2af0
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
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	[USP'U]/g; mg/g; [USP'U]/g
Substance Name	BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE
Labeler Name	Trifecta Pharmaceuticals USA LLC
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	2023-12-31

Package

Package Images

NDC 69396-0062-09 (69396006209)

Pricing Information	N/A
NDC Package Code	69396-062-09
Billing NDC	69396006209
Package	144 PACKET in 1 CARTON (69396-062-09) / .9 g in 1 PACKET
Marketing Start Date	2020-05-29
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL a7bfa4b5-72b7-334a-e053-2a95a90aed3d Details

Active Ingredient

Bacitracin Zinc 400 Units

Purpose

First Aid Antibiotic

Active ingredient

Neomycin 3.5 mg

Purpose

First Aid Antibiotic

Active Ingredient

Polymyxin B Sulfate 5000 Units

Purpose

First Aid Antibiotic

Uses

First Aid to help prevent infection in minor:

cuts
scrapes
burns

Warnings

For External Use Only.

Ask Doctor before use if you have

deep or puncture wounds

animal bites

serious burns

Do Not Use

in eyes
over large areas of the body
if you are allergic to any of the ingredients

Stop Use and Ask Doctor if

If you need to use longer than 1 week
The condition persists or gets worse
A rash or allergic reaction develops

Directions

Clean the affected area and dry thoroughly
Apply a small amount of the 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

Inactive Ingredients

mineral oil and petrolatum

Questions

Call 1-888-296-9067

Fax: 1-888-878-3609

Online: www.trifecta-pharma.com

Reorder No. 1012SL

Storage Information

Store at 20° to 25°C (68° to 77°F).

Keep out of reach of children

If swallowed, get medical help or contact a Poison Control Center immediately.

Other Information

Distributed By:

Trifecta Pharmaceuticals USA®

Ft. Lauderdale, FL. 33301 USA

Made in USA

Packaging

INGREDIENTS AND APPEARANCE

TRIPLE ANTIBIOTIC

bacitracin zinc, neomycin sulfate, polymyxin b sulfate ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:69396-062
Route of Administration	TOPICAL

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

Ingredient Name	Strength
Inactive Ingredients
PETROLATUM (UNII: 4T6H12BN9U)
MINERAL OIL (UNII: T5L8T28FGP)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:69396-062-09	144 in 1 CARTON	05/29/2020
1		0.9 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	04/20/2020

Labeler - Trifecta Pharmaceuticals USA LLC (079424163)

Revised: 1/2022

Document Id: d57ad01b-76dc-58e3-e053-2a95a90a2af0

Set id: a7bfa4b5-72b7-334a-e053-2a95a90aed3d

Version: 2

Effective Time: 20220113

Search by Drug Name or NDC

NDC 69396-0062-09 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 69396-0062-09 (69396006209)

Contents

Standard Product Labeling (SPL)/Prescribing Information SPL a7bfa4b5-72b7-334a-e053-2a95a90aed3d Details

Active Ingredient

Purpose

Active ingredient

Purpose

Active Ingredient

Purpose

Uses

Warnings

Ask Doctor before use if you have

Do Not Use

Stop Use and Ask Doctor if

Directions

Inactive Ingredients

Questions

Storage Information

Keep out of reach of children

Other Information

Packaging

INGREDIENTS AND APPEARANCE

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