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NDC 50382-0006-20 Bacitracin Zinc 500 [iU]/g Details

Bacitracin Zinc 500 [iU]/g

Bacitracin Zinc is a TOPICAL OINTMENT in the HUMAN OTC DRUG category. It is labeled and distributed by Galentic Pharma (India) Private Limited. The primary component is BACITRACIN ZINC.

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: 50382-0006-20
Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Bacitracin Topical

Product Information

NDC	50382-0006
Product ID	50382-006_ee22a881-536d-ea69-e053-2a95a90a33fe
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 Zinc
Proprietary Name Suffix	n/a
Non-Proprietary Name	Bacitracin Zinc
Product Type	HUMAN OTC DRUG
Dosage Form	OINTMENT
Route	TOPICAL
Active Ingredient Strength	500
Active Ingredient Units	[iU]/g
Substance Name	BACITRACIN ZINC
Labeler Name	Galentic Pharma (India) Private Limited
Pharmaceutical Class	Decreased Cell Wall Synthesis & Repair [PE]
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH FINAL
Application Number	part333B
Listing Certified Through	2023-12-31

Package

Package Images

NDC 50382-0006-20 (50382000620)

Pricing Information	N/A
NDC Package Code	50382-006-20
Billing NDC	50382000620
Package	12 JAR in 1 CASE (50382-006-20) / 425 g in 1 JAR
Marketing Start Date	2017-08-07
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 4a92eec1-eb71-4aef-b6fa-b7257ecc0984 Details

• ACTIVE INGREDIENT

Active Ingredient (each gram contains)

Bacitracin Zinc 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
if you are allergic to any of the ingredients
over large areas of the body
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

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 immediately.

• DIRECTIONS

Clean the affected area
Apply a small amount of this 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

• OTHER INFORMATION

Store at 15° to 30°C (59° to 86°F)
Lot No. & Exp. Date. See box or crimp of tube.

• INACTIVE INGREDIENT

Hard Paraffin, Liquid Paraffin, White Soft Paraffin

SPL UNCLASSIFIED SECTION

Manufactured by : Galentic Pharma (India) Pvt. Ltd., Plot No. 5-B & 5-C, Sector III, Kandla Special Economic Zone,

Gandhidham-370 230, Gujarat. India

PRINCIPAL DISPLAY PANEL - 28 g Tube Carton

Galentic

Bacitracin

Ointment

FIRST AID ANTIBIOTIC

BACITRACIN

ZINC

Helps to Heal Burns, Scrapes & Cuts

Prevents Infections

NET WT.

1 OZ. (28g)

PRINCIPAL DISPLAY PANEL - 28 g Tube Carton

INGREDIENTS AND APPEARANCE

BACITRACIN ZINC

bacitracin zinc ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:50382-006
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
BACITRACIN ZINC (UNII: 89Y4M234ES) (BACITRACIN - UNII:58H6RWO52I)	BACITRACIN	500 [iU] in 1 g

Ingredient Name	Strength
Inactive Ingredients
MINERAL OIL (UNII: T5L8T28FGP)
PETROLATUM (UNII: 4T6H12BN9U)
PARAFFIN (UNII: I9O0E3H2ZE)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:50382-006-11	144 in 1 CARTON	08/07/2017
1		0.9 g in 1 PACKET; Type 0: Not a Combination Product
2	NDC:50382-006-12	1 in 1 CARTON	08/07/2013
2		14.2 g in 1 TUBE; Type 0: Not a Combination Product
3	NDC:50382-006-13	1 in 1 CARTON	08/07/2013
3		28 g in 1 TUBE; Type 0: Not a Combination Product
4	NDC:50382-006-16	1 in 1 CARTON	08/07/2013
4		113 g in 1 TUBE; Type 0: Not a Combination Product
5	NDC:50382-006-20	12 in 1 CASE	08/07/2017
5		425 g in 1 JAR; Type 0: Not a Combination Product
6	NDC:50382-006-21	25 in 1 CARTON	08/07/2013
6		0.9 g in 1 PACKET; 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	08/07/2013

Labeler - Galentic Pharma (India) Private Limited (915110464)

Name	Address	ID/FEI	Business Operations
Establishment
Galentic Pharma (India) Private Limited		650970176	manufacture(50382-006) , pack(50382-006) , sterilize(50382-006) , analysis(50382-006)

Revised: 11/2022

Document Id: ee22a881-536d-ea69-e053-2a95a90a33fe

Set id: 4a92eec1-eb71-4aef-b6fa-b7257ecc0984

Version: 5

Effective Time: 20221123