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

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.

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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

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

Other information

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 AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BACITRACIN ZINC (UNII: 89Y4M234ES) (BACITRACIN - UNII:58H6RWO52I) BACITRACIN417.8 [iU]  in 1 g
POLYMYXIN B SULFATE (UNII: 19371312D4) (POLYMYXIN B - UNII:J2VZ07J96K) POLYMYXIN B5322.8 [iU]  in 1 g
NEOMYCIN SULFATE (UNII: 057Y626693) (NEOMYCIN - UNII:I16QD7X297) NEOMYCIN3.5 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
PETROLATUM (UNII: 4T6H12BN9U)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:59898-740-02144 in 1 BOX, UNIT-DOSE03/30/2010
10.9 g in 1 PACKET; Type 0: Not a Combination Product
2NDC:59898-740-0325 in 1 BOX, UNIT-DOSE03/30/2010
20.9 g in 1 PACKET; Type 0: Not a Combination Product
3NDC:59898-740-011728 in 1 CARTON03/30/2010
30.9 g in 1 PACKET; Type 0: Not a Combination Product
4NDC:59898-740-381728 in 1 CARTON03/30/2010
40.5 g in 1 PACKET; Type 0: Not a Combination Product
5NDC:59898-740-340.9 g in 1 PACKET; Type 0: Not a Combination Product03/30/2010
6NDC:59898-740-360.5 g in 1 PACKET; Type 0: Not a Combination Product03/30/2010
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333B03/30/2010
Labeler - Water-Jel Technologies (155522589)
Establishment
NameAddressID/FEIBusiness Operations
Water-Jel Technologies155522589manufacture(59898-740)

Revised: 11/2017
Document Id: 5e332a38-e153-d2c4-e053-2a91aa0abb49
Set id: d5fcaffd-af38-4285-a79c-6df7424c76fa
Version: 15
Effective Time: 20171116
 
Water-Jel Technologies