FIRST AID ANTISEPTIC- benzalkonium chloride spray 
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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First Aid Antiseptic Spray

Active ingredient

Benzalkonium chloride 0.13%

Purpose

First aid antiseptic

Uses

first aid to help prevent infection in minor cuts, scrapes and burns

Warnings

For external use only

Do not use

  • in the eyes or apply over large areas of the body
  • longer than 1 week unless directed by a doctor

Ask a doctor before use if you have

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

Stop use and ask a doctor if

  • the condition persists or gets worse

Keep out of the reach of children

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

Directions

Other information

Inactive ingredients


diazolidinyl urea, edetate disodium, glycerin, hypromellose, methylparaben, octoxynol-9, propylene glycol, propylparaben, triethanolamine, water

Questions or comments?


1-800-275-3433 info@waterjel.com www.waterjel.com
Manufactered by Water-Jel Technologies, Inc., 50 Broad Street,
Carlstadt, NJ 07072, USA

Principal Display Panel

AS2

FIRST AID ANTISEPTIC 
benzalkonium chloride spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59898-401
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.13 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
EDETATE DISODIUM (UNII: 7FLD91C86K)  
OCTOXYNOL 9 (UNII: 7JPC6Y25QS)  
GLYCERIN (UNII: PDC6A3C0OX)  
TROLAMINE (UNII: 9O3K93S3TK)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
WATER (UNII: 059QF0KO0R)  
HYPROMELLOSE 2208 (100000 MPA.S) (UNII: VM7F0B23ZI)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:59898-401-1059 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product05/22/2010
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A05/22/2010
Labeler - Water-Jel Technologies (155522589)
Registrant - Water-Jel Technologies (155522589)
Establishment
NameAddressID/FEIBusiness Operations
Water-Jel Technologies155522589manufacture(59898-401)

Revised: 12/2020
Document Id: b70375bd-ddfd-b150-e053-2a95a90a3bc1
Set id: 2b3cb958-c0c4-47fd-8338-7c7821135f2b
Version: 5
Effective Time: 20201221
 
Water-Jel Technologies