Bacitracin by Sion Biotext Medical Ltd BACITRACIN ointment

Bacitracin by

Drug Labeling and Warnings

Bacitracin by is a Otc medication manufactured, distributed, or labeled by Sion Biotext Medical Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

Active ingredient               Purpose

Bacitracin 500 Units                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, serious burns.
  

Other information

• store at controlled room temperature 15°-30° C (59°-86° F)

Inactive ingredients

Light Mineral Oil, White Petrolatum

Indications and Usage

• clean the affected areas
• apply a small amount (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

Stop use and ask a doctor if:

• if condition persist or gets worse
• a rash or other allergic reaction develops

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.
  

Dosage and Administration

• Do not use over large areas of the body, longer than 1 week unless directed by a doctor
• apply a small amount (an amount equal to the surface area of the tip of the finger) on the area 1 to 3 times daily

Principal Display Panel

NDC: 68786-218-01/02/03/04/05/06/07

BACITRACIN OINTMENT

FIRST AID ANTIBIOTIC

NET WT 1 oz. (28.4 g)

INGREDIENTS AND APPEARANCE

BACITRACIN 
bacitracin ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68786-218
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: 68786-218-01	12 in 1 CASE	07/09/2012
1		144 in 1 BOX
1		0.9 g in 1 PACKET; Type 0: Not a Combination Product
2	NDC: 68786-218-03	72 in 1 CASE	07/09/2012
2		14.17 g in 1 TUBE; Type 0: Not a Combination Product
3	NDC: 68786-218-04	72 in 1 CASE	07/09/2012
3		28.35 g in 1 TUBE; Type 0: Not a Combination Product
4	NDC: 68786-218-02	12 in 1 CASE	07/09/2012
4		144 in 1 BOX
4		0.5 g in 1 PACKET; Type 0: Not a Combination Product
5	NDC: 68786-218-05	72 in 1 CASE	07/09/2012
5		56.8 g in 1 TUBE; Type 0: Not a Combination Product
6	NDC: 68786-218-06	72 in 1 CASE	07/09/2012
6		113.6 g in 1 TUBE; Type 0: Not a Combination Product
7	NDC: 68786-218-07	12 in 1 CASE	07/09/2012
7		426 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	07/09/2012

Labeler - Sion Biotext Medical Ltd (532775194)

Establishment
Name	Address	ID/FEI	Business Operations
Sion Biotext Medical Ltd		532775194	manufacture(68786-218)