Skip to Content
Print Share

The originating document has been archived. We cannot confirm the completeness, accuracy and currency of the content.

b4 Antiseptic Hand Sanitizer Benzalkonium Chloride 0.13%

Dosage form: gel
Ingredients: BENZALKONIUM CHLORIDE 1.3mg in 1mL
Labeler: Midway Advanced Products LLC
NDC Code: 52490-500

b4 Antiseptic Hand Sanitizer Benzalkonium Chloride Gel 0.13%

Active ingredient

Benzalkonium chloride 0.13%

Purpose

Antiseptic

Use

For handwashing to decrease bacteria on the skin.

Warnings

​For external use only

​Do not use​

  • in the eyes

​Stop use and ask a doctor if

  • irritation and redness develop
  • if condition persists for more than 72 hours.

Keep out of reach of children.

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

Directions

Wet hands thoroughly with product and allow to dry without wiping

Other information

store at room temperature

Inactive ingredients

butylene glycol, caesalpinia spinosa gum, citric acid, ethylhexylgycerin, fragrance, glycerin, phenoxyethanol, sodium lauryl sulfate, water

Package Labeling:

B4 ANTISEPTIC HAND SANITIZER BENZALKONIUM CHLORIDE 0.13% 
benzalkonium chloride gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52490-500
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZALKONIUM CHLORIDE (BENZALKONIUM) BENZALKONIUM CHLORIDE1.3 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER 
BUTYLENE GLYCOL 
GLYCERIN 
CAESALPINIA SPINOSA RESIN 
SODIUM LAURYL SULFATE 
CITRIC ACID MONOHYDRATE 
PHENOXYETHANOL 
ETHYLHEXYLGLYCERIN 
Packaging
#Item CodePackage Description
1NDC:52490-500-1515 mL in 1 TUBE
2NDC:52490-500-20500 TUBE in 1 CARTON
215 mL in 1 TUBE
3NDC:52490-500-010.7 mL in 1 PACKAGE
4NDC:52490-500-16100 mL in 1 BOTTLE
5NDC:52490-500-21100 BOTTLE in 1 CARTON
5100 mL in 1 BOTTLE
6NDC:52490-500-312000 PACKAGE in 1 CARTON
60.7 mL in 1 PACKAGE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E05/15/201707/13/2020
Labeler - Midway Advanced Products LLC (962765009)

Revised: 07/2018
Document Id: 70ba45c1-80e4-f255-e053-2a91aa0ac227
Set id: f7bba189-ac8e-4d97-a869-8ad40bdc7cd1
Version: 6
Effective Time: 20180711
 
Midway Advanced Products LLC

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Medical Disclaimer