WATER-JEL 3-IN-1 ANTIBIOTIC- bacitracin zinc, polymyxin b sulfate, neomycin sulfate ointment

Water-Jel 3-in-1 Antibiotic by

Drug Labeling and Warnings

Water-Jel 3-in-1 Antibiotic by is a Otc medication manufactured, distributed, or labeled by Water-Jel Technologies. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients (each gram contains)

Bacitracin zinc 400 units

Neomycin sulfate (5 mg equivalent to 3.5 mg Neomycin base)

Polymyxin B sulfate 5000 units

Purpose

First aid antibiotic

First aid antibiotic

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 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
  

Ask a doctor before use if you have

• a deep or puncture wounds, animal bites, or serious burns
  

Stop use and ask a doctor if

Keep out of the reach of children

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

Directions

• clean the affected area
• apply a small amount of product (an amount equal 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
  

Other information

• store at 15 o to 25 oC (59 o to 77 oF)
• tamper evident sealed packets
• do not use any opened or torn packets
• you may report a serious adverse reaction to this product to 800 275-3433
  

Inactive ingredient

petrolatum

Questions or comments?

800-275-3433 

info@waterjel.com   www.waterjel.com

Principal Display Panel

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INGREDIENTS AND APPEARANCE

WATER-JEL 3-IN-1 ANTIBIOTIC 
bacitracin zinc, polymyxin b sulfate, neomycin sulfate ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 59898-740
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BACITRACIN ZINC (UNII: 89Y4M234ES) (BACITRACIN - UNII:58H6RWO52I)	BACITRACIN	417.8 [iU]  in 1 g
POLYMYXIN B SULFATE (UNII: 19371312D4) (POLYMYXIN B - UNII:J2VZ07J96K)	POLYMYXIN B	5322.8 [iU]  in 1 g
NEOMYCIN SULFATE (UNII: 057Y626693) (NEOMYCIN - UNII:I16QD7X297)	NEOMYCIN	3.5 mg  in 1 g

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 59898-740-02	144 in 1 BOX, UNIT-DOSE	03/30/2010
1		0.9 g in 1 PACKET; Type 0: Not a Combination Product
2	NDC: 59898-740-03	25 in 1 BOX, UNIT-DOSE	03/30/2010
2		0.9 g in 1 PACKET; Type 0: Not a Combination Product
3	NDC: 59898-740-01	1728 in 1 CARTON	03/30/2010
3		0.9 g in 1 PACKET; Type 0: Not a Combination Product
4	NDC: 59898-740-38	1728 in 1 CARTON	03/30/2010
4		0.5 g in 1 PACKET; Type 0: Not a Combination Product
5	NDC: 59898-740-34	0.9 g in 1 PACKET; Type 0: Not a Combination Product	03/30/2010
6	NDC: 59898-740-36	0.5 g in 1 PACKET; Type 0: Not a Combination Product	03/30/2010

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333B	03/30/2010

Labeler - Water-Jel Technologies (155522589)

Establishment
Name	Address	ID/FEI	Business Operations
Water-Jel Technologies		155522589	manufacture(59898-740)