BACITRACIN ZINC ointment

Bacitracin Zinc by

Drug Labeling and Warnings

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

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredient                                               Purpose
Bacitracin Zinc (500 Units in each gram)               First Aid Antibiotic

Warnings:

For external use only

DOSAGE & ADMINISTRATION:

• clean the affected areas, Apply a small amount of 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

Stop use and ask a doctor if

Stop use and ask a doctor if the condition persists or gets worse, or if a rash or other allergic reaction develops.

Indications & Usage:

• in the eyes or over large areas of the body 
• if you are allergic to any of the ingredients
• longer than 1 week unless directed by a doctor

Keep out of reach of children

KEEP OUT OF REACH OF CHILDREN

If swallowed, get medical help or contact a Poison Control Center right away

Purpose:

First aid to help prevent infection in minor cuts, scrapes, and burns.

Other information

• store at controlled room temperature
• Avoid excessive heat and humidity
• Tamper Evident. Do not use if inner seal is torn, cut or open.

Ask a doctor if

Ask a doctor before use if you have deep or puncture wounds, animal bites, or serious burns.

Inactive ingredients

Hard Paraffin, Liquid Paraffin, White Soft Paraffin

Principal Display Panel

Dynarex Bacitracin Zinc Ointment:

1175 ESG.jpg

INGREDIENTS AND APPEARANCE

BACITRACIN ZINC 
bacitracin zinc ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 67777-220
Route of Administration	TOPICAL

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

Inactive Ingredients
Ingredient Name	Strength
PETROLATUM (UNII: 4T6H12BN9U)
LIGHT MINERAL OIL (UNII: N6K5787QVP)
MINERAL OIL (UNII: T5L8T28FGP)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 67777-220-02	28.35 g in 1 TUBE; Type 0: Not a Combination Product	12/01/2009
2	NDC: 67777-220-03	14.17 g in 1 TUBE; Type 0: Not a Combination Product	12/01/2009
3	NDC: 67777-220-04	113.4 g in 1 TUBE; Type 0: Not a Combination Product	12/01/2009
4	NDC: 67777-220-07	425.3 g in 1 JAR; Type 0: Not a Combination Product	12/01/2009
5	NDC: 67777-220-05	0.5 g in 1 PACKET; Type 0: Not a Combination Product	12/01/2009
6	NDC: 67777-220-01	0.9 g in 1 PACKET; Type 0: Not a Combination Product	12/01/2009

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333B	12/01/2009

Labeler - Dynarex Corporation (008124539)

Registrant - Dynarex Corporation (008124539)

Establishment
Name	Address	ID/FEI	Business Operations
Galentic Pharma (India) Pvt. Ltd.		864201135	manufacture(67777-220)

Establishment
Name	Address	ID/FEI	Business Operations
Galentic Pharma (India) Private Limited		650970176	manufacture(67777-220)