BACITRACIN ZINC ointment

Bacitracin Zinc by

Drug Labeling and Warnings

Bacitracin Zinc 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 Zinc (equal to 500 Bacitracin units)                 Antibiotic

Uses:

First aid to help prevent infection in:

• Minor cuts
• scrapes
  
• burns
  

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)
• Avoid excessive heat and humidity
• tamper evident. Do not use if packet is torn, cut or open.
  

Inactive ingredients

Hard Paraffin, Liquid Paraffin, White Soft Paraffin

Directions

• clean the affected area
• apply a small amount of this product ( an equal amount to the surface area of the tip of a finger) on the area 1 to 3 times daily
• may be covered with a sterile bandage
  

Stop use and ask a doctor if:

• the condition persists 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.
  

Indications and Usage

• First aid to help prevent infections
• Not for ophthalmic use
  

Warnings

• FOR EXTERNAL USE ONLY
• Not for ophthalmic use.
  

PRINCIPAL DISPLAY PANEL

Sion Biotext Medical Ltd

Bacitracin Zinc Ointment

SBM Bacitracin Zinc.jpg

INGREDIENTS AND APPEARANCE

BACITRACIN ZINC 
bacitracin zinc ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68786-220
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BACITRACIN ZINC (UNII: 89Y4M234ES) (BACITRACIN - UNII:58H6RWO52I)	BACITRACIN ZINC	500 [iU]  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: 68786-220-02	72 in 1 CASE	07/06/2012
1		28.35 g in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 68786-220-01	12 in 1 CASE	07/06/2012
2		144 in 1 BOX
2		0.9 g in 1 PACKET; Type 0: Not a Combination Product
3	NDC: 68786-220-03	72 in 1 CASE	07/06/2012
3		14.2 g in 1 TUBE; Type 0: Not a Combination Product
4	NDC: 68786-220-04	72 in 1 CASE	07/06/2012
4		113.4 g in 1 TUBE; Type 0: Not a Combination Product
5	NDC: 68786-220-05	12 in 1 CASE	07/06/2012
5		144 in 1 BOX
5		0.5 g in 1 PACKET; Type 0: Not a Combination Product
6	NDC: 68786-220-06	72 in 1 CASE	07/06/2012
6		56.8 g in 1 TUBE; Type 0: Not a Combination Product
7	NDC: 68786-220-07	12 in 1 CASE	07/06/2012
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	07/06/2012

Labeler - Sion Biotext Medical Ltd (532775194)

Establishment
Name	Address	ID/FEI	Business Operations
Sion Biotext Medical Ltd		532775194	manufacture(68786-220)