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NDC 00363-0539-64 triple antibiotic 400; 3.5; 5000 [USP'U]/g; mg/g; [USP'U]/g Details

triple antibiotic 400; 3.5; 5000 [USP'U]/g; mg/g; [USP'U]/g

triple antibiotic is a TOPICAL OINTMENT in the HUMAN OTC DRUG category. It is labeled and distributed by Walgreen Company. 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: 00363-0539-64
Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Neomycin, Polymyxin, and Bacitracin Topical

Product Information

NDC	00363-0539
Product ID	0363-0539_ce7ad9cf-3416-42f6-93b5-d9f18138d5b8
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	triple antibiotic
Proprietary Name Suffix	n/a
Non-Proprietary Name	bacitracin zinc, neomycin, polymyxin B
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	Walgreen Company
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 00363-0539-64 (00363053964)

Pricing Information	N/A
NDC Package Code	0363-0539-64
Billing NDC	00363053964
Package	1 TUBE in 1 CARTON (0363-0539-64) / 28 g in 1 TUBE
Marketing Start Date	2015-05-07
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 4f3cfe39-2df8-48b4-954d-5997217c92ba Details

SPL UNCLASSIFIED SECTION

Drug Facts

SPL UNCLASSIFIED SECTION

Active ingredients(in each gram)	Purpose
Bacitracin zinc 400 units	First aid antibiotic
Neomycin sulfate 3.5 mg	First aid antibiotic
Polymyxin B sulfate 5,000 units	First aid antibiotic

Use

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

Warnings

For external use only.

Do not use

if you are allergic to any of the ingredients
in the eyes
over large areas of the body

Ask a doctor before use if you have

deep or puncture wounds
animal bites
serious burns

Stop use and ask a doctor if

you need to use longer than 1 week
condition persists or gets worse
rash or other allergic reaction develops

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away: 800-222-1222.

Directions

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

Other information

store at 15 to 30°C (59 to 86°F)
Tamper Evident: DO NOT USE IF SEAL ON TUBE IS BROKEN OR MISSING.

Inactive ingredient

petrolatum

Questions or comments?

866-323-0107

SPL UNCLASSIFIED SECTION

DISTRIBUTED BY: WALGREEN CO.

200 WILMOT RD., DEERFIELD, IL 60015

PRINCIPAL DISPLAY PANEL - 2 Tube Carton

TWIN PACK

NDC 0363-0539-26

Walgreens

Compare to the active ingredients in

Neosporin® Original Ointment††

• WALLGREENS •

PHARMACIST RECOMMENDED†

Triple

Antibiotic

Ointment

BACITRACIN ZINC / NEOMYCIN SULFATE / POLYMYXIN B

SULFATE / FIRST AID ANTIBIOTIC

Original Strength

Triple Antibiotic

First aid antibiotic ointment
Helps prevent infection in minor cuts, scrapes & burns

2

TUBES

2 OZ (56 g) EACH, NET WT 4 OZ (112 g)

INGREDIENTS AND APPEARANCE

TRIPLE ANTIBIOTIC

bacitracin zinc, neomycin, polymyxin b ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:0363-0539
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
NEOMYCIN SULFATE (UNII: 057Y626693) (NEOMYCIN - UNII:I16QD7X297)	NEOMYCIN	3.5 mg in 1 g
POLYMYXIN B SULFATE (UNII: 19371312D4) (POLYMYXIN B - UNII:J2VZ07J96K)	POLYMYXIN B	5000 [USP'U] in 1 g

Ingredient Name	Strength
Inactive Ingredients
PETROLATUM (UNII: 4T6H12BN9U)
COCOA BUTTER (UNII: 512OYT1CRR)
COTTONSEED OIL (UNII: H3E878020N)
OLIVE OIL (UNII: 6UYK2W1W1E)
SODIUM PYRUVATE (UNII: POD38AIF08)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)

Product Characteristics
Color	WHITE (Translucent)	Score
Shape		Size
Flavor		Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:0363-0539-58	1 in 1 CARTON	08/26/2015
1		14 g in 1 TUBE; Type 0: Not a Combination Product
2	NDC:0363-0539-64	1 in 1 CARTON	05/07/2015
2		28 g in 1 TUBE; Type 0: Not a Combination Product
3	NDC:0363-0539-16	1 in 1 CARTON	08/29/2015
3		56 g in 1 TUBE; Type 0: Not a Combination Product
4	NDC:0363-0539-26	2 in 1 CARTON	11/24/2015
4		56 g in 1 TUBE; 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	05/07/2015

Labeler - Walgreen Company (008965063)

Name	Address	ID/FEI	Business Operations
Establishment
Natureplex LLC		062808196	MANUFACTURE(0363-0539)

Revised: 10/2022

Document Id: ce7ad9cf-3416-42f6-93b5-d9f18138d5b8

Set id: 4f3cfe39-2df8-48b4-954d-5997217c92ba

Version: 10

Effective Time: 20221026

Search by Drug Name or NDC

NDC 00363-0539-64 triple antibiotic 400; 3.5; 5000 [USP'U]/g; mg/g; [USP'U]/g Details

triple antibiotic 400; 3.5; 5000 [USP'U]/g; mg/g; [USP'U]/g

MedlinePlus Drug Summary

Product Information

Package

Package Images

NDC 00363-0539-64 (00363053964)

Contents

Standard Product Labeling (SPL)/Prescribing Information SPL 4f3cfe39-2df8-48b4-954d-5997217c92ba Details

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

Use

Warnings

Do not use

Ask a doctor before use if you have

Stop use and ask a doctor if

Directions

Other information

Inactive ingredient

Questions or comments?

SPL UNCLASSIFIED SECTION

PRINCIPAL DISPLAY PANEL - 2 Tube Carton

INGREDIENTS AND APPEARANCE

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