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NDC 00404-0167-50 Bacitracin Zinc, Neomycin Sulfate, and Polymyxin B Sulfate 400; 5; 5000 [iU]/g; mg/g; [iU]/g Details

Bacitracin Zinc, Neomycin Sulfate, and Polymyxin B Sulfate 400; 5; 5000 [iU]/g; mg/g; [iU]/g

Bacitracin Zinc, Neomycin Sulfate, and Polymyxin B Sulfate is a TOPICAL OINTMENT in the HUMAN OTC DRUG category. It is labeled and distributed by Henry Schein. The primary component is BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE.

Product Information

NDC	00404-0167
Product ID	0404-0167_ead9496b-112f-59e6-e053-2995a90a768c
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, Neomycin Sulfate, and Polymyxin B Sulfate
Proprietary Name Suffix	n/a
Non-Proprietary Name	Bacitracin Zinc, Neomycin Sulfate, and Polymyxin B Sulfate
Product Type	HUMAN OTC DRUG
Dosage Form	OINTMENT
Route	TOPICAL
Active Ingredient Strength	400; 5; 5000
Active Ingredient Units	[iU]/g; mg/g; [iU]/g
Substance Name	BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE
Labeler Name	Henry Schein
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 00404-0167-50 (00404016750)

Pricing Information	N/A
NDC Package Code	0404-0167-50
Billing NDC	00404016750
Package	1728 BOX in 1 CASE (0404-0167-50) / 144 PACKET in 1 BOX / .9 g in 1 PACKET
Marketing Start Date	2022-11-03
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL ead9496b-112e-59e6-e053-2995a90a768c Details

Active Ingredient

Bacitracin Zinc 400 units

Neomyxin Sulfate 5mg (Equivalent to 3.5mg Neomycin)

Polymyxin B Sulfate 5000 units

Purpose

First Aid Antibiotic

Uses

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 before use if you have

Deep or puncture wounds, animal bites, or serious burns

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-86°F)

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

Inactive Ingredients

White Petrolatum

Label

Triple Antibiotic Label

INGREDIENTS AND APPEARANCE

BACITRACIN ZINC, NEOMYCIN SULFATE, AND POLYMYXIN B SULFATE

bacitracin zinc, neomycin sulfate, and polymyxin b sulfate ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:0404-0167
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
BACITRACIN ZINC (UNII: 89Y4M234ES) (BACITRACIN - UNII:58H6RWO52I)	BACITRACIN ZINC	400 [iU] in 1 g
NEOMYCIN SULFATE (UNII: 057Y626693) (NEOMYCIN - UNII:I16QD7X297)	NEOMYCIN SULFATE	5 mg in 1 g
POLYMYXIN B SULFATE (UNII: 19371312D4) (POLYMYXIN B - UNII:J2VZ07J96K)	POLYMYXIN B	5000 [iU] in 1 g

Ingredient Name	Strength
Inactive Ingredients
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:0404-0167-50	1728 in 1 CASE	11/03/2022
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	11/03/2022

Labeler - Henry Schein (012430880)

Registrant - Dynarex (008124539)

Revised: 10/2022

Document Id: ead9496b-112f-59e6-e053-2995a90a768c

Set id: ead9496b-112e-59e6-e053-2995a90a768c

Version: 1

Effective Time: 20221012