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NDC 50382-0006-21 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.

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 50382-0006-21 (50382000621)

Pricing Information	N/A
NDC Package Code	50382-006-21
Billing NDC	50382000621
Package	25 PACKET in 1 CARTON (50382-006-21) / .9 g in 1 PACKET
Marketing Start Date	2013-08-07
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