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NDC 47682-0223-99 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 Unifirst First Aid Corporation. 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: 47682-0223-99
Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Neomycin, Polymyxin, and Bacitracin Topical

Product Information

NDC	47682-0223
Product ID	47682-223_ec1ddd2f-7809-57f8-e053-2995a90aa67a
Associated GPIs	90109803104200
GCN Sequence Number	061415
GCN Sequence Number Description	neomycin/bacitracin/polymyxinB OINT PACK 3.5-400-5K TOPICAL
HIC3	Q5W
HIC3 Description	TOPICAL ANTIBIOTICS
GCN	97206
HICL Sequence Number	033356
HICL Sequence Number Description	NEOMYCIN SULFATE/BACITRACIN ZINC/POLYMYXIN B
Brand/Generic	Brand
Proprietary Name	Triple Antibiotic
Proprietary Name Suffix	n/a
Non-Proprietary Name	bacitracin zinc, neomycin sulfate, polymyxin b sulfate
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	Unifirst First Aid Corporation
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 47682-0223-99 (47682022399)

Pricing Information	N/A
NDC Package Code	47682-223-99
Billing NDC	47682022399
Package	.5 g in 1 POUCH (47682-223-99)
Marketing Start Date	2013-04-25
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL d265f094-e654-4c68-9215-b5d061af885d Details

SPL UNCLASSIFIED SECTION

Drug Facts

SPL UNCLASSIFIED SECTION

Active ingredients (each gram)

Bacitracin zinc (400 units Bacitracin)

Neomycin sulfate 5 mg (3.5 mg Neomycin)

Polymyxin-B sulfate (Polymyxin B 5000 units)

SPL UNCLASSIFIED SECTION

Purposes

First Aid Antibiotics

SPL UNCLASSIFIED SECTION

Uses

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

SPL UNCLASSIFIED SECTION

Warnings

For external use only

Do not use

in the eyes
internally
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

in case of 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 immediately.

SPL UNCLASSIFIED SECTION

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

SPL UNCLASSIFIED SECTION

Other information

store at room temperature (do not freeze)
tamper evident. Do not use if packet is torn, cut or opened.

SPL UNCLASSIFIED SECTION

Inactive ingredients

petrolatum

SPL UNCLASSIFIED SECTION

Questions or comments? 1-800-634-7680

Medi-First Triple Antibiotic Ointment Label

Medi-First®

Triple Antibiotic Ointment

Bacitracin Zinc / Neomycin Sulfate / Polymycin B Sulfate

First Aid Antibiotic

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

0.5g (1/57oz) Packets / 25 per box

INGREDIENTS AND APPEARANCE

TRIPLE ANTIBIOTIC

bacitracin zinc, neomycin sulfate, polymyxin b sulfate ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:47682-223
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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
BACITRACIN ZINC (UNII: 89Y4M234ES) (BACITRACIN - UNII:58H6RWO52I)	BACITRACIN	400 [USP'U] in 1 g

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

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:47682-223-12	10 in 1 BOX	04/25/2013
1	NDC:47682-223-99	0.5 g in 1 POUCH; Type 0: Not a Combination Product
2	NDC:47682-223-73	25 in 1 BOX	04/25/2013
2	NDC:47682-223-99	0.5 g in 1 POUCH; Type 0: Not a Combination Product
3	NDC:47682-223-35	144 in 1 BOX	04/25/2013
3	NDC:47682-223-99	0.5 g in 1 POUCH; Type 0: Not a Combination Product
4	NDC:47682-223-99	0.5 g in 1 POUCH; Type 0: Not a Combination Product	04/25/2013

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part333B	04/25/2013

Labeler - Unifirst First Aid Corporation (832947092)

Name	Address	ID/FEI	Business Operations
Establishment
Safetec of America, Inc.		874965262	manufacture(47682-223)

Revised: 10/2022

Document Id: ec1ddd2f-7809-57f8-e053-2995a90aa67a

Set id: d265f094-e654-4c68-9215-b5d061af885d

Version: 11

Effective Time: 20221028

Search by Drug Name or NDC

NDC 47682-0223-99 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 47682-0223-99 (47682022399)

Contents

Standard Product Labeling (SPL)/Prescribing Information SPL d265f094-e654-4c68-9215-b5d061af885d Details

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

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Medi-First Triple Antibiotic Ointment Label

INGREDIENTS AND APPEARANCE

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