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NDC 00904-6679-67 Major Bacitracin Zinc 500 [USP'U]/g Details

Major Bacitracin Zinc 500 [USP'U]/g

Major Bacitracin Zinc is a TOPICAL OINTMENT in the HUMAN OTC DRUG category. It is labeled and distributed by Major Pharmaceuticals. The primary component is BACITRACIN ZINC.

MedlinePlus Drug Summary

Bacitracin is used to help prevent minor skin injuries such as cuts, scrapes, and burns from becoming infected. Bacitracin is in a class of medications called antibiotics. Bacitracin works by stopping the growth of bacteria.

Related Packages: 00904-6679-67
Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Bacitracin Topical

Product Information

NDC	00904-6679
Product ID	0904-6679_c74b8735-2476-4d17-a8c8-a9a0db7e69d3
Associated GPIs	90100010104210
GCN Sequence Number	030028
GCN Sequence Number Description	bacitracin zinc OINT PACK 500 UNIT/G TOPICAL
HIC3	Q5W
HIC3 Description	TOPICAL ANTIBIOTICS
GCN	31813
HICL Sequence Number	006091
HICL Sequence Number Description	BACITRACIN ZINC
Brand/Generic	Generic
Proprietary Name	Major Bacitracin Zinc
Proprietary Name Suffix	n/a
Non-Proprietary Name	Bacitracin Zinc
Product Type	HUMAN OTC DRUG
Dosage Form	OINTMENT
Route	TOPICAL
Active Ingredient Strength	500
Active Ingredient Units	[USP'U]/g
Substance Name	BACITRACIN ZINC
Labeler Name	Major Pharmaceuticals
Pharmaceutical Class	Decreased Cell Wall Synthesis & Repair [PE]
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH FINAL
Application Number	part333B
Listing Certified Through	2024-12-31

Package

Package Images

NDC 00904-6679-67 (00904667967)

Pricing Information	N/A
NDC Package Code	0904-6679-67
Billing NDC	00904667967
Package	144 PACKET in 1 CARTON (0904-6679-67) / .9 g in 1 PACKET
Marketing Start Date	2018-09-28
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 661c84bf-f496-4532-9306-0c5b77e1dad9 Details

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredients (In each gram)

Bacitracin 500

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 20º-25ºC (68° to 77°F)

Inactive ingredient

Petrolatum

Questions? 1-800-616-2471

PRINCIPAL DISPLAY PANEL

Principal Display Panel – Carton Label

Major NDC 0904-6679-67

Bacitracin Zinc Ointment USP

Bacitracin Zinc 500 units

144 Unit dose Packets

First Aid Antibiotic Ointment

NET WT. 0.9g (0.03oz)

PRINCIPAL DISPLAY PANEL

Principal Display Panel – Packet Label

Major NDC 0904-6679-67

Bacitracin Zinc Ointment

Bacitracin Zinc 500 Units

144 Unit Dose Packets

First Aid Antibiotic Ointment

Protection against Infection

NET WT. 0.9g (0.03oz)

INGREDIENTS AND APPEARANCE

MAJOR BACITRACIN ZINC

bacitracin zinc ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:0904-6679
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Bacitracin Zinc (UNII: 89Y4M234ES) (Bacitracin - UNII:58H6RWO52I)	Bacitracin	500 [USP'U] in 1 g

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

Product Characteristics
Color	white	Score
Shape		Size
Flavor		Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:0904-6679-67	144 in 1 CARTON	09/28/2018
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	09/28/2018

Labeler - Major Pharmaceuticals (191427277)

Registrant - Major Pharmaceuticals (191427277)

Revised: 1/2021

Document Id: c74b8735-2476-4d17-a8c8-a9a0db7e69d3

Set id: 661c84bf-f496-4532-9306-0c5b77e1dad9

Version: 2

Effective Time: 20210114

Search by Drug Name or NDC

NDC 00904-6679-67 Major Bacitracin Zinc 500 [USP'U]/g Details

Major Bacitracin Zinc 500 [USP'U]/g

MedlinePlus Drug Summary

Product Information

Package

Package Images

NDC 00904-6679-67 (00904667967)

Contents

Standard Product Labeling (SPL)/Prescribing Information SPL 661c84bf-f496-4532-9306-0c5b77e1dad9 Details

SPL UNCLASSIFIED SECTION

Active ingredients (In each gram)

Purpose

Uses

Warnings

Allergy alert:

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? 1-800-616-2471

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

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