Water-Jel 3-in-1 Antibiotic

Dosage form: ointment
Ingredients: BACITRACIN ZINC 417.8[iU] in 1g, POLYMYXIN B SULFATE 5322.8[iU] in 1g, NEOMYCIN SULFATE 3.5mg in 1g
Labeler: Water-Jel Technologies
NDC Code: 59898-740

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Triple Antibiotic Ointment

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
  • the condition persists or gets worse
  • a rash or other allergic reaction develops

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 15o to 25oC (59o to 77oF)
  • 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

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WATER-JEL 3-IN-1 ANTIBIOTIC 
bacitracin zinc, polymyxin b sulfate, neomycin sulfate ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59898-740
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BACITRACIN ZINC (BACITRACIN) BACITRACIN417.8 [iU]  in 1 g
POLYMYXIN B SULFATE (POLYMYXIN B) POLYMYXIN B5322.8 [iU]  in 1 g
NEOMYCIN SULFATE (NEOMYCIN) NEOMYCIN3.5 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
PETROLATUM 
Packaging
#Item CodePackage Description
1NDC:59898-740-02144 PACKET (PACKET) in 1 BOX, UNIT-DOSE
10.9 g in 1 PACKET
2NDC:59898-740-0325 PACKET (PACKET) in 1 BOX, UNIT-DOSE
20.9 g in 1 PACKET
3NDC:59898-740-011728 PACKET (PACKET) in 1 CARTON
30.9 g in 1 PACKET
4NDC:59898-740-340.9 g in 1 PACKET
5NDC:59898-740-360.5 g in 1 PACKET
6NDC:59898-740-3228 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333B03/30/2010
Labeler - Water-Jel Technologies (155522589)
Establishment
NameAddressID/FEIOperations
Water-Jel Technologies155522589manufacture(59898-740)

Revised: 04/2013
 
Water-Jel Technologies

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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