Search by Drug Name or NDC

NDC 49687-0013-00 Antibiotic Application 400; 3.5; 5000 [iU]/g; mg/g; [iU]/g Details

Antibiotic Application 400; 3.5; 5000 [iU]/g; mg/g; [iU]/g

Antibiotic Application is a TOPICAL OINTMENT in the HUMAN OTC DRUG category. It is labeled and distributed by CMC Group, Inc.. 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: 49687-0013-00
Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Neomycin, Polymyxin, and Bacitracin Topical

Product Information

NDC	49687-0013
Product ID	49687-0013_b856e34d-85f6-0ab0-e053-2a95a90ab549
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	Antibiotic Application
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	[iU]/g; mg/g; [iU]/g
Substance Name	BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE
Labeler Name	CMC Group, Inc.
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 49687-0013-00 (49687001300)

Pricing Information	N/A
NDC Package Code	49687-0013-0
Billing NDC	49687001300
Package	10 PACKAGE in 1 KIT (49687-0013-0) / .9 g in 1 PACKAGE
Marketing Start Date	2016-08-06
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL da436c35-a98f-4df7-9d23-885564734cef Details

Drug Facts

Active ingredients (in each gram)

Bacitracin zinc (bacitracin 400 units)

Neomycin sulfate (neomycin 3.5mg)

Polymyxin B sulfate (polymyxin B 5,000 units)

Purpose

First aid antibiotic

Use

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

Warnings

For external use only.

Do not use

• in the eyes • over large areas of the body • if you are allergic to any of the ingredient • longer than 1 week unless directed by a doctor.

Ask a doctor before use if you have

• deep or punture wounds • animal bites • 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 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

Inactive ingredients

Mineral oil, petrolatum, purified water

Package Labeling:

INGREDIENTS AND APPEARANCE

ANTIBIOTIC APPLICATION

bacitracin zinc, neomycin sulfate, polymyxin b sulfate ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:49687-0013
Route of Administration	TOPICAL

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

Ingredient Name	Strength
Inactive Ingredients
MINERAL OIL (UNII: T5L8T28FGP)
PETROLATUM (UNII: 4T6H12BN9U)
WATER (UNII: 059QF0KO0R)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:49687-0013-0	10 in 1 KIT	08/06/2016
1		0.9 g in 1 PACKAGE; 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	08/06/2016

Labeler - CMC Group, Inc. (117201448)

Revised: 1/2021

Document Id: b856e34d-85f6-0ab0-e053-2a95a90ab549

Set id: da436c35-a98f-4df7-9d23-885564734cef

Version: 6

Effective Time: 20210107