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NDC 36800-0536-64 Antibiotic 500 [USP'U]/g Details

Antibiotic 500 [USP'U]/g

Antibiotic is a TOPICAL OINTMENT in the HUMAN OTC DRUG category. It is labeled and distributed by Topco Associates LLC. The primary component is BACITRACIN.

MedlinePlus Drug Summary

Bacitracin is used to help prevent minor skin injuries such as cuts, scrapes, and burns from becoming infected. Bacitracin is in a class of medications called antibiotics. Bacitracin works by stopping the growth of bacteria.

Related Packages: 36800-0536-64
Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Bacitracin Topical

Product Information

NDC	36800-0536
Product ID	36800-536_db5a21bd-60c1-4484-86f7-51f5e4df1ca7
Associated GPIs	90100010004210
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
Proprietary Name Suffix	n/a
Non-Proprietary Name	bacitracin
Product Type	HUMAN OTC DRUG
Dosage Form	OINTMENT
Route	TOPICAL
Active Ingredient Strength	500
Active Ingredient Units	[USP'U]/g
Substance Name	BACITRACIN
Labeler Name	Topco Associates LLC
Pharmaceutical Class	Decreased Cell Wall Synthesis & Repair [PE]
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH FINAL
Application Number	part333B
Listing Certified Through	2024-12-31

Package

Package Images

NDC 36800-0536-64 (36800053664)

Pricing Information	N/A
NDC Package Code	36800-536-64
Billing NDC	36800053664
Package	1 TUBE in 1 CARTON (36800-536-64) / 28 g in 1 TUBE
Marketing Start Date	2020-04-03
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 3267a695-9e53-42f2-b30a-022653a0b8bb Details

Active ingredient (each gram contains)

Bacitracin 500 units

Purpose

First aid antibiotic

Uses

first aid to help prevent infection in:

•: minor cuts
•: scrapes
•: 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 ingredients

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.

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 20°-25°C (68°-77°F)

Inactive ingredients

light mineral oil, white petrolatum

Questions or comments?

1-888-423-0139

Package/Label Principal Display Panel

First Aid Antibiotic Ointment

Helps Prevent Infection in Minor Cuts, Scrapes & Burns

TopCare® health

Antibiotic Ointment

BACITRACIN, USP

First Aid Antibiotic Ointment

NET WT 1 OZ (28 g)

INGREDIENTS AND APPEARANCE

ANTIBIOTIC

bacitracin ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:36800-536
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
BACITRACIN (UNII: 58H6RWO52I) (BACITRACIN - UNII:58H6RWO52I)	BACITRACIN	500 [USP'U] in 1 g

Ingredient Name	Strength
Inactive Ingredients
LIGHT MINERAL OIL (UNII: N6K5787QVP)
PETROLATUM (UNII: 4T6H12BN9U)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:36800-536-64	1 in 1 CARTON	04/03/2020
1		28 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	04/03/2020

Labeler - Topco Associates LLC (006935977)

Revised: 3/2022

Document Id: db5a21bd-60c1-4484-86f7-51f5e4df1ca7

Set id: 3267a695-9e53-42f2-b30a-022653a0b8bb

Version: 3

Effective Time: 20220304