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NDC 00904-6680-67 Major Triple Antibiotic 400; 3.5; 5000 [USP'U]/g; mg/g; [USP'U]/g Details

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

Major Triple Antibiotic is a TOPICAL OINTMENT in the HUMAN OTC DRUG category. It is labeled and distributed by Major Pharmaceuticals. 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: 00904-6680-67
Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Neomycin, Polymyxin, and Bacitracin Topical

Product Information

NDC	00904-6680
Product ID	0904-6680_789e49e8-03f4-42d4-866d-8ef534ba8fb4
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	Major Triple Antibiotic
Proprietary Name Suffix	n/a
Non-Proprietary Name	Bacitracin Zinc, Polymyxin B Sulfate, Neomycin 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	Major Pharmaceuticals
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 00904-6680-67 (00904668067)

Pricing Information	N/A
NDC Package Code	0904-6680-67
Billing NDC	00904668067
Package	144 PACKET in 1 CARTON (0904-6680-67) / .9 g in 1 PACKET
Marketing Start Date	2018-10-04
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL fa696eab-aa51-4f5f-ae34-6e41100c92a1 Details

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredients (In each gram)

Bacitracin 400

Neomycin 3.5 mg

Polymyxin B 5,000 units

Purpose

First aid antibiotic

Uses

First aid to help prevent infection in minor:

cuts
scrapes
burns

Warnings

For external use only

Allergy Alert do not use if you are allergic to any of the ingredients

Do not use

in or near the eyes
on large areas of the body

Consult 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

Stop use and consult a doctor if

condition persists or gets worse
symptoms last for more than 7 days or clear up and come back within a few days
a rash or other allergic reaction develops

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

Directions

clean the affected area
apply a small amount (equal to surface area of tip of finger) on the area 1 to 3 times daily.
may be covered with a sterile bandage

Other information

Store at a controlled room temperature 20°C to 25°C(68º-77ºF)

Inactive ingredient

Petrolatum

Questions? 1-800-616-2417

PRINCIPAL DISPLAY PANEL

Principal Display Panel – Carton Label

Major NDC 0904-6680-67

Triple Antibiotic Ointment

144 Unit Dose Packets

Bacitracin Zinc • Neomycin Sulfate • Polymyxin-B Sulfate

First Aid Antibiotic Ointment

Prevents infaction in Minor

Cuts
Burns
Scraps

NET WT. 0.9 g (0.03 oz ) PACKETS

PRINCIPAL DISPLAY PANEL

Principal Display Panel – Packet Label

Major NDC 0904-6680-67

Triple Antibiotic OintmentBacitracin Zinc • Neomycin Sulfate • Polymyxin-B Sulfate

First Aid Antibiotic Ointment

First Aid Treatment for Minor Cuts, Scrapes and Burns

NET WT 0.9g (0.03oz)

INGREDIENTS AND APPEARANCE

MAJOR TRIPLE ANTIBIOTIC

bacitracin zinc, polymyxin b sulfate, neomycin sulfate ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:0904-6680
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
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

Ingredient Name	Strength
Inactive Ingredients
Petrolatum (UNII: 4T6H12BN9U)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:0904-6680-67	144 in 1 CARTON	10/04/2018
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	10/04/2018

Labeler - Major Pharmaceuticals (191427277)

Registrant - Major Pharmaceuticals (191427277)

Revised: 1/2021

Document Id: 789e49e8-03f4-42d4-866d-8ef534ba8fb4

Set id: fa696eab-aa51-4f5f-ae34-6e41100c92a1

Version: 3

Effective Time: 20210114

Search by Drug Name or NDC

NDC 00904-6680-67 Major Triple Antibiotic 400; 3.5; 5000 [USP'U]/g; mg/g; [USP'U]/g Details

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

MedlinePlus Drug Summary

Product Information

Package

Package Images

NDC 00904-6680-67 (00904668067)

Contents

Standard Product Labeling (SPL)/Prescribing Information SPL fa696eab-aa51-4f5f-ae34-6e41100c92a1 Details

SPL UNCLASSIFIED SECTION

Active ingredients (In each gram)

Purpose

Uses

Warnings

Do not use

Consult a doctor before use if you have

When using this product

Stop use and consult a doctor if

Directions

Other information

Inactive ingredient

Questions? 1-800-616-2417

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

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