BACITRACIN ZINC- bacitracin zinc ointment
Galentic Pharma (India) Private Limited

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Bacitracin Zinc Ointment

• 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

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

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

Galentic Pharma (India) Private Limited