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NDC 00904-8804-67 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: 00904-8804-67
Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Bacitracin Topical

Product Information

NDC	00904-8804
Product ID	0904-8804_d5f49180-b73c-c075-e053-2995a90a89fd
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	2023-12-31

Package

Package Images

NDC 00904-8804-67 (00904880467)

Pricing Information	N/A
NDC Package Code	0904-8804-67
Billing NDC	00904880467
Package	144 PACKET in 1 CARTON (0904-8804-67) / .9 g in 1 PACKET
Marketing Start Date	2020-05-29
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL a6cb8abe-c009-2674-e053-2a95a90a2d5c Details

Active Ingredient

Bacitracin Zinc 500

Purpose

First Aid Antibiotic

Uses

First Aid to help prevent infection in

minor cuts
scrapes
burns

Warnings

For External Use Only.

Do Not Use

in eyes
over large areas of the body
if you are allergic to any of the ingredients, due to the possiblity of anaphylactic shock
longer than 1 week unless directed by a doctor

Stop Use and Ask Doctor if

Before use in case of deep puncture wounds, animal bites or serious burns
The condition persists or gets worse
A rash or allergic reaction develops

Directions

Clean the affected area
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, white petrolatum

Questions

Call 1-800-616-2471

Storage Information

Avoid excessive heat and humidity

Store at room temperature 15° to 30°C (59° to 86°F).

Keep out of reach of children

If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Other Information

Tamper evident. Do not use if packet is torn, cut or opened.

Distributed By:

MAJOR® PHARMACEUTICALS

17177 N Laurel Park Drive

Suite 233

Livonia, MI 48152

Product of USA

Packaging

INGREDIENTS AND APPEARANCE

MAJOR BACITRACIN ZINC

bacitracin zinc ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:0904-8804
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)
MINERAL OIL (UNII: T5L8T28FGP)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:0904-8804-67	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	04/01/2020

Labeler - Major Pharmaceuticals (191427277)

Registrant - Trifecta Pharmaceuticals USA LLC (079424163)

Revised: 1/2022

Document Id: d5f49180-b73c-c075-e053-2995a90a89fd

Set id: a6cb8abe-c009-2674-e053-2a95a90a2d5c

Version: 2

Effective Time: 20220119