BACITRACIN ZINC ointment

Bacitracin Zinc by

Drug Labeling and Warnings

Bacitracin Zinc by is a Otc medication manufactured, distributed, or labeled by Galentic Pharma (India) Private Limited. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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)

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

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

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
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

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333B	08/07/2013

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

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