DURISAN  HAND SANITIZER- benzalkonium chloride liquid 
Sanit Technologies 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.

----------

Durisan Hand Sanitizer - 611

Active Ingredient

Benzalkonium Chloride 0.13%

Purpose

Antiseptic

Keep out of reach of children

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately.

Usage

  • To decrease bacteria on the skin

Warnings

For External use only

When using this product • Keep out of eyes. In case of contact, flush eyes with water.

When Using

When using this product • Keep out of eyes. In case of contact, flush eyes with water.

Stop Use

Stop use and consult a doctor if irritation or redness develops.

Directions

  • Rub thoroughly over all surfaces of both hands.
  • Rub hands together briskly until dry.

Inactive Ingredients

Water, cetrimonium chloride, laurtrimonium chloride, dihydroxyethyl cocoamine oxide, glycereth – 17 cocoate , propyl glycol, diazolidinyl urea, methyl paraben , propyl paraben , citric acid, dihdroxypropyl PEG -5 linoleammonium chloride

Product labels

image description

image description

image description

image description

image description

image description

image description

image description

image description

image description

DURISAN   HAND SANITIZER
benzalkonium chloride liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71120-611
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE2.5 mg  in 250 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
DIHYDROXYPROPYL PEG-5 LINOLEAMMONIUM CHLORIDE (UNII: 0Y0NQR2GH1)  
GLYCERETH-17 COCOATE (UNII: 3057VPT0KC)  
DIHYDROXYETHYL COCAMINE OXIDE (UNII: 8AR51R3BL5)  
CETRIMONIUM CHLORIDE (UNII: UC9PE95IBP)  
LAURTRIMONIUM CHLORIDE (UNII: A81MSI0FIC)  
1,3-PROPANEDIOL BIS(4-AMINOBENZOATE) (UNII: 8860R9ORQR)  
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:71120-611-0120 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product01/01/201611/23/2020
2NDC:71120-611-0250 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product01/01/201611/23/2020
3NDC:71120-611-03250 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product01/01/201611/23/2020
4NDC:71120-611-04550 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product01/01/201611/23/2020
5NDC:71120-611-053785 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product01/01/201611/23/2020
6NDC:71120-611-061000 mL in 1 CONTAINER; Type 0: Not a Combination Product01/01/201611/23/2020
7NDC:71120-611-07118 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product01/01/201611/23/2020
8NDC:71120-611-08237 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product01/01/201611/23/2020
9NDC:71120-611-094 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product01/01/201602/28/2020
10NDC:71120-611-108 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product01/01/201602/28/2020
11NDC:71120-611-11300 mL in 1 CONTAINER; Type 0: Not a Combination Product01/01/201611/23/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E01/01/201611/23/2020
Labeler - Sanit Technologies LLC (075711022)
Establishment
NameAddressID/FEIBusiness Operations
Organics Corporation of America DBA Ambix Laboratories061061164manufacture(71120-611)
Establishment
NameAddressID/FEIBusiness Operations
Sanit Technologies LLC dba Durisan075711022manufacture(71120-611)
Establishment
NameAddressID/FEIBusiness Operations
Lab Express International800875106relabel(71120-611) , api manufacture(71120-611) , repack(71120-611)

Revised: 2/2021
 
Sanit Technologies LLC