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NDC 00404-0172-50 Bacitracin Zinc 500 [iU]/g Details

Bacitracin Zinc 500 [iU]/g

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

Product Information

NDC	00404-0172
Product ID	0404-0172_eaf03943-c7a6-724e-e053-2995a90a3e6c
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	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	[iU]/g
Substance Name	BACITRACIN ZINC
Labeler Name	Henry Schein
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 00404-0172-50 (00404017250)

Pricing Information	N/A
NDC Package Code	0404-0172-50
Billing NDC	00404017250
Package	1728 BOX in 1 CASE (0404-0172-50) / 144 PACKET in 1 BOX / .9 g in 1 PACKET
Marketing Start Date	2022-11-07
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL eaf03943-c7a5-724e-e053-2995a90a3e6c Details

Active Ingredient

Bacitracin Zinc (500 units)

Purpose

First Aid Antibiotic

Use(s)

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

Warnings

For External Use Only

Do not use

• In the eyes or over large areas of the body

• If you are allergic to any of the ingredients

• Longer than 1 week unless directed by a doctor

Ask a doctor or pharmacist before use if you have

deep or puncture wounds, animal bites, or serious burns

When using this product

there are no side effects.

Stop use and ask a doctor if

• The condition persists or gets worse

• A rash or other allergic reaction develops

Keep out of reach of children

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

• Store at room temperature 15º-30ºC (59º-86ºF)

• Avoid excessive heat and humidity

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

Inactive Ingredients

Mineral Oil, Paraffin, White Petrolatum

Questions?

1-888-396-2739 M-F 9-5 EST

Label

Bacitracin Zinc

INGREDIENTS AND APPEARANCE

BACITRACIN ZINC

bacitracin zinc ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:0404-0172
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
BACITRACIN ZINC (UNII: 89Y4M234ES) (BACITRACIN - UNII:58H6RWO52I)	BACITRACIN ZINC	500 [iU] in 1 g

Ingredient Name	Strength
Inactive Ingredients
MINERAL OIL (UNII: T5L8T28FGP)
PARAFFIN (UNII: I9O0E3H2ZE)
WHITE PETROLATUM (UNII: B6E5W8RQJ4)

Product Characteristics
Color		Score
Shape	FREEFORM	Size
Flavor		Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:0404-0172-50	1728 in 1 CASE	11/07/2022
1		144 in 1 BOX
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	11/07/2022

Labeler - Henry Schein (012430880)

Revised: 10/2022

Document Id: eaf03943-c7a6-724e-e053-2995a90a3e6c

Set id: eaf03943-c7a5-724e-e053-2995a90a3e6c

Version: 1

Effective Time: 20221013