Search by Drug Name or NDC

NDC 63187-0299-01 Bacitracin 500 [iU]/g Details

Bacitracin 500 [iU]/g

Bacitracin is a TOPICAL OINTMENT in the HUMAN OTC DRUG category. It is labeled and distributed by Proficient Rx LP. 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: 63187-0299-01
Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Bacitracin Topical

Product Information

NDC	63187-0299
Product ID	63187-299_bdce10e2-9374-480a-bd44-cb7f7a49148e
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
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	[iU]/g
Substance Name	BACITRACIN
Labeler Name	Proficient Rx LP
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 63187-0299-01 (63187029901)

Pricing Information	N/A
NDC Package Code	63187-299-01
Billing NDC	63187029901
Package	28.35 g in 1 TUBE (63187-299-01)
Marketing Start Date	2019-01-01
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL e1166948-5d80-44c2-a20d-78be631647d9 Details

SPL UNCLASSIFIED SECTION

Active ingredient Purpose

Bacitracin 500 Units Antibiotic

Warnings:

For external use only

Dosage and Administration:

•: clean the affected areas
•: apply a small amount of product (an amount equal to the surface area of the tip of the finger) on the area 1 to 3 times daily
•: may be covered with a sterile bandage

Stop use and ask a doctor if

•: the condition persists or gets worse, or if a rash or other allergic reaction develops.

Do not use:

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

Keep out of reach of children

if swallowed, get medical help or contact a Poison Control Center right away

Purpose

First aid to help prevent infection in:

Minor cuts

scrapes

burns

Indications and Usage

Ask a doctor before use:

•: in case of deep or puncture wounds
•: animal bites
•: serious burns

Other information

•: store at controlled room temperature 15°-30° C (59°-86° F)

Inactive ingredients

Light Mineral Oil, White Petrolatum

Principal Display Panel

Relabeled By:

Proficient Rx LP

Thousand Oaks, CA 91320

Bacitracin Ointment:

bacitracin-galentic-ointment-01.jpg

INGREDIENTS AND APPEARANCE

BACITRACIN

bacitracin ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:63187-299(NDC:67777-219)
Route of Administration	TOPICAL

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

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

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:63187-299-01	28.35 g in 1 TUBE; Type 0: Not a Combination Product	01/01/2019

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part333B	12/01/2009

Labeler - Proficient Rx LP (079196022)

Name	Address	ID/FEI	Business Operations
Establishment
Proficient Rx LP		079196022	REPACK(63187-299) , RELABEL(63187-299)

Revised: 1/2021

Document Id: bdce10e2-9374-480a-bd44-cb7f7a49148e

Set id: e1166948-5d80-44c2-a20d-78be631647d9

Version: 4

Effective Time: 20210104