FIRST AID ANTISEPTIC- benzalkonium chloride spray

First Aid Antiseptic by

Drug Labeling and Warnings

First Aid Antiseptic by is a Otc medication manufactured, distributed, or labeled by Water-Jel Technologies. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

• clean the affected area
• spray a small amount of this product on the area 1 to 3 times daily
• may be covered with a sterile bandage
• if bandaged, let dry first
  

Other information

• shake well
• store at room temperature
• you may report a serious adverse reaction to this product to 1-800-275-3433

Inactive ingredients

diazolidinyl urea, edetate disodium, glycerin, hypromellose, methylparaben, octoxynol 9, propylene glycol, propylparaben, purified water, trolamine

Questions or comments?

1-800-275-3433  info@waterjel.com   www.waterjel.com

Principal Display Panel

INGREDIENTS AND APPEARANCE

FIRST AID ANTISEPTIC 
benzalkonium chloride spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 59898-401
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	0.13 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
PROPYLPARABEN (UNII: Z8IX2SC1OH)
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)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 59898-401-10	59 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	05/22/2010

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	05/22/2010

Labeler - Water-Jel Technologies (155522589)

Registrant - Water-Jel Technologies (155522589)

Establishment
Name	Address	ID/FEI	Business Operations
Water-Jel Technologies		155522589	manufacture(59898-401)