ANTISEPTIC HAND SANITIZER ALCOHOL FREE VALENCIA GROUP- benzalkonium chloride gel 
Midway Advanced Products, LLC

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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Antiseptic Hand Sanitizer Alcohol Free Valencia Group

​Drug Facts

​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
  • condition persists for more than 72 hours

Keep out of reach of children.

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

​Directions

  • wet hands thoroughly with product
  • allow to dry without wiping

​Other information

  • store at room temperature

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

Hand Sanitizer 0.7mL

Sachet

Hand Sanitizer 100 mL x 100 Carton

Carton

Hand sanitizer 100 mL

Bottle

Hand Sanitizer Valencia

52490-501-23 Label

ANTISEPTIC HAND SANITIZER ALCOHOL FREE VALENCIA GROUP 
benzalkonium chloride gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52490-501
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE1.3 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
CAESALPINIA SPINOSA RESIN (UNII: WL3883U2PO)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
GLYCERIN (UNII: PDC6A3C0OX)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:52490-501-030.7 mL in 1 PACKET; Type 0: Not a Combination Product01/24/201804/10/2020
2NDC:52490-501-222000 in 1 CARTON01/24/201804/10/2020
20.7 mL in 1 PACKET; Type 0: Not a Combination Product
3NDC:52490-501-40100 mL in 1 BOTTLE; Type 0: Not a Combination Product01/24/201805/18/2020
4NDC:52490-501-23100 in 1 CARTON02/01/201805/18/2020
4100 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E01/24/201805/18/2020
Labeler - Midway Advanced Products, LLC (962765009)

Revised: 7/2018
Document Id: 70ba379a-6e2f-48c1-e053-2991aa0ae4f5
Set id: 04893caa-24d4-488d-bea8-974d8dc80bd3
Version: 2
Effective Time: 20180711
 
Midway Advanced Products, LLC