Bacitracin by Galentic Pharma (India) Priva Te Limited BACITRACIN ointment

Bacitracin by

Drug Labeling and Warnings

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

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredient               Purpose
Bacitracin 500 Units                Antibiotic

Purpose:

First aid to help prevent infection.

Warnings:

For external use only

Dosage and Administration

Directions:

• clean the affected areas
• apply a small amount of product (an amountb 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

Indications and Usage

First aid to help prevent infection in:

• minor cuts
• scrapes
• burns

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:

• 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

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

Bacitracin Ointment:

Gal Bacitracin.jpg

INGREDIENTS AND APPEARANCE

BACITRACIN 
bacitracin ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 50382-005
Route of Administration	TOPICAL

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

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 50382-005-01	28.35 g in 1 TUBE
2	NDC: 50382-005-02	14.17 g in 1 TUBE
3	NDC: 50382-005-03	56.7 g in 1 TUBE
4	NDC: 50382-005-04	113.4 g in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333B	08/02/2013

Labeler - Galentic Pharma (India) Priva Te Limited (918531450)

Establishment
Name	Address	ID/FEI	Business Operations
Galentic Pharma (India) Priva Te Limited		918531450	manufacture(50382-005)