DURISAN HAND SANITIZER- benzalkonium chloride liquid

Durisan by

Drug Labeling and Warnings

Durisan by is a Otc medication manufactured, distributed, or labeled by Sanit Technologies LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

Benzalkonium Chloride 0.1%

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.

Dosage

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

Inactive Ingredients

Inactive ingredients: water, laurtrimonium chloride, cetrimonium chloride, glycereth-17 cocoate, dihydroxyethyl cocamine oxide, dihydroxypropyl PEG-5, linoeammonium chloride, citric acid

Durisan Hand Sanitizer 50 ml

• Drug Facts Active Ingredient Purpose Benzalkonium Chloride 0.1% ………….…. Antiseptic Uses 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. Stop use and consult a doctor if irritation or redness develops. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately. Directions Rub thoroughly over all surfaces of both hands. Rub hands together briskly until dry. Inactive ingredients: water, laurtrimonium chloride, cetrimonium chloride, glycereth-17 cocoate, dihydroxyethyl cocamine oxide, dihydroxypropyl PEG-5, linoeammonium chloride, citric acid:

  Item # Travel

  DHS-0501 Size

  Durisan ®

  • ANTIMICROBIAL SOLUTIONS

  HAND

  SANITIZER

  ALCOHOL-FREE

  LONG-LASTING

  NO ODOR

  U.S. Patent # 10,058,094

  POWERED BY

  ® SANIT TECHNOLOGIES LLC

  50 ml

  Net Content 1.69 oz

• 8 52379 00612 7:

  Sanit Technologies, LLC

  7810 25th Court East Unit 106

  Sarasota, Florida 34243

  844-DURISAN

Durisan Hand Sanitizer 118 ml

Durisan ® ANTIMICROBIAL SOLUTIONS HAND SANITIZER ALCOHOL-FREE LONG-LASTING NO ODOR U.S. Patent # 10,058,094 POWERED BY ® SANIT TECHNOLOGIES LLC 118 ml Net Content 4 oz Item # DHS-1004

Drug Facts Active Ingredient                                       Purpose            Benzalkonium Chloride 0.1% ………….…. Antiseptic Uses 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. Stop use and consult a doctor if irritation or redness develops. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately. Directions Rub thoroughly over all surfaces of both hands. Rub hands together briskly until dry. Inactive ingredients: water, laurtrimonium chloride, cetrimonium chloride, glycereth-17 cocoate, dihydroxyethyl cocamine oxide, dihydroxypropyl PEG-5, linoeammonium chloride, citric acid

8     52379   00634    9

Sanit Technologies, LLC 7810 25th Court East Unit 106 Sarasota, Florida 34243 844-DURISAN

Durisan 236

Durisan ® ANTIMICROBIAL SOLUTIONS HAND SANITIZER ALCOHOL-FREE LONG-LASTING NO ODOR U.S. Patent # 10,058,094 POWERED BY ® SANIT TECHNOLOGIES LLC 236.58ml Net Content 8 oz

Drug Facts Active Ingredient                                       Purpose             Benzalkonium Chloride 0.1% ………….…. Antiseptic Uses 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. Stop use and consult a doctor if irritation or redness develops. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately. Directions Rub thoroughly over all surfaces of both hands. Rub hands together briskly until dry. Inactive ingredients: water, laurtrimonium chloride, cetrimonium chloride, glycereth-17 cocoate, dihydroxyethyl cocamine oxide, dihydroxypropyl PEG-5, linoeammonium chloride, citric acid

Item # DHS-1012 8     52379   00635    6

Sanit Technologies, LLC 7810 25th Court East Unit 106 Sarasota, Florida 34243 844-DURISAN www.DURISAN.com

Durisan Hand Sanitizer 250 ml

• Drug Facts Active Ingredient Purpose Benzalkonium Chloride 0.1% ………….…. Antiseptic Uses 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. Stop use and consult a doctor if irritation or redness develops. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately. Directions Rub thoroughly over all surfaces of both hands. Rub hands together briskly until dry. Inactive ingredients: water, laurtrimonium chloride, cetrimonium chloride, glycereth-17 cocoate, dihydroxyethyl cocamine oxide, dihydroxypropyl PEG-5, linoeammonium chloride, citric acid:

  Durisan ®

  • ANTIMICROBIAL SOLUTIONS

  HAND

  SANITIZER

  ALCOHOL-FREE

  LONG-LASTING

  NO ODOR

  U.S. Patent # 10,058,094

  POWERED BY

  ® SANIT TECHNOLOGIES LLC

  250 ml

  Net Content 8.45 oz

• ITEM # DHS-2501 8 52379 00611 0:

  Sanit Technologies, LLC

  7810 25th Court East

  Sarasota, Florida 34243

  844-DURISAN

  www.DURISAN.com

Durisan Hand Sanitizer 300 ml

Durisan ® ANTIMICROBIAL SOLUTIONS ALCOHOL-FREE HAND SANITIZER Up to 24 hour protection Proudly mad in the USA 300 ml Net Content 10 oz

Drug Facts Active Ingredient                                       Purpose            Benzalkonium Chloride 0.1% ………….…. Antiseptic Uses 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. Stop use and consult a doctor if irritation or redness develops. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately. Directions Rub thoroughly over all surfaces of both hands. Rub hands together briskly until dry. Inactive ingredients: water, laurtrimonium chloride, cetrimonium chloride, glycereth-17 cocoate, dihydroxyethyl cocamine oxide, dihydroxypropyl PEG-5, linoeammonium chloride, citric acid

Item # RTHS-3000 8     52379   00697    4

Sanit Technologies, LLC 7810 25th Court East Sarasota, Florida 34243 844-DURISAN U.S. Patent # 10,058,094

Durisan Hand Sanitizer 550 ml

Drug Facts Active Ingredient                                       Purpose            Benzalkonium Chloride 0.1% ………….…. Antiseptic Uses 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. Stop use and consult a doctor if irritation or redness develops. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately. Directions Rub thoroughly over all surfaces of both hands. Rub hands together briskly until dry. Inactive ingredients: water, laurtrimonium chloride, cetrimonium chloride, glycereth-17 cocoate, dihydroxyethyl cocamine oxide, dihydroxypropyl PEG-5, linoeammonium chloride, citric acid			Durisan ® ANTIMICROBIAL SOLUTIONS HAND SANITIZER ALCOHOL-FREE LONG-LASTING NO ODOR U.S. Patent # 10,058,094 POWERED BY ® SANIT TECHNOLOGIES LLC 550 ml Net Content 18.59 oz
8    52379  00620    2	ITEM # DHS-0550 844-DURISAN www.DURISAN.com	Sanit Technologies, LLC 7810 25th Court East Sarasota, Florida 34243

Durisan Hand Sanitizer 1000 ml

Durisan ® ANTIMICROBIAL SOLUTIONS HAND SANITIZER ALCOHOL-FREE LONG-LASTING NO ODOR U.S. Patent # 10,058,094 POWERED BY ® SANIT TECHNOLOGIES LLC 1000 ml Net Content 33.81 oz

Drug Facts Active Ingredient                                       Purpose            Benzalkonium Chloride 0.1% ………….…. Antiseptic Uses 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. Stop use and consult a doctor if irritation or redness develops. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately. Directions Rub thoroughly over all surfaces of both hands. Rub hands together briskly until dry. Inactive ingredients: water, laurtrimonium chloride, cetrimonium chloride, glycereth-17 cocoate, dihydroxyethyl cocamine oxide, dihydroxypropyl PEG-5, linoeammonium chloride, citric acid

0.4 Item # DHS-1002 8     50008   48507    7

Sanit Technologies, LLC 7810 25th Court East Sarasota, Florida 34243 844-DURISAN www.DURISAN.com

Drug Facts Active Ingredient                                       Purpose            Benzalkonium Chloride 0.1% ………….…. Antiseptic Uses 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. Stop use and consult a doctor if irritation or redness develops. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately. Directions Rub thoroughly over all surfaces of both hands. Rub hands together briskly until dry. Inactive ingredients: water, laurtrimonium chloride, cetrimonium chloride, glycereth-17 cocoate, dihydroxyethyl cocamine oxide, dihydroxypropyl PEG-5, linoeammonium chloride, citric acid

0.8 Item # DHS-1008 8     52379   00610    3

Sanit Technologies, LLC 7810 25th Court East Sarasota, Florida 34243 844-DURISAN www.DURISAN.COM

Durisan Hand Sanitizer 1 Gallon

Sanit Technologies, LLC 7810 25th Court East Sarasota, Florida 34243 844-DURISAN www.DURISAN.com ITEM # DHS-3785 8    52379  00621    9

Drug Facts Active Ingredient                                       Purpose            Benzalkonium Chloride 0.1% ………….…. Antiseptic Uses 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. Stop use and consult a doctor if irritation or redness develops. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately. Directions Rub thoroughly over all surfaces of both hands. Rub hands together briskly until dry. Inactive ingredients: water, laurtrimonium chloride, cetrimonium chloride, glycereth-17 cocoate, dihydroxyethyl cocamine oxide, dihydroxypropyl PEG-5, linoeammonium chloride, citric acid

Durisan ® ANTIMICROBIAL SOLUTIONS HAND SANITIZER ALCOHOL-FREE LONG-LASTING NO ODOR U.S. Patent # 10,058,094 POWERED BY ® SANIT TECHNOLOGIES LLC 1 Gallon Net Content 128 oz

INGREDIENTS AND APPEARANCE

DURISAN  HAND SANITIZER
benzalkonium chloride liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71120-611
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	2.5 mg  in 250 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
DIHYDROXYPROPYL PEG-5 LINOLEAMMONIUM CHLORIDE (UNII: 0Y0NQR2GH1)
GLYCERETH-2 COCOATE (UNII: JWM00VS7HC)
BEHENTRIMONIUM CHLORIDE (UNII: X7GNG3S47T)
DIHYDROXYETHYL COCAMINE OXIDE (UNII: 8AR51R3BL5)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71120-611-01	20 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	01/01/2016	02/28/2020
2	NDC: 71120-611-02	50 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	01/01/2016
3	NDC: 71120-611-03	250 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	01/01/2016
4	NDC: 71120-611-04	550 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	01/01/2016
5	NDC: 71120-611-05	3785 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	01/01/2016
6	NDC: 71120-611-06	1000 mL in 1 CONTAINER; Type 0: Not a Combination Product	01/01/2016
7	NDC: 71120-611-07	118 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	01/01/2016
8	NDC: 71120-611-08	237 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	01/01/2016
9	NDC: 71120-611-09	4 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	01/01/2016	02/28/2020
10	NDC: 71120-611-10	8 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	01/01/2016	02/28/2020
11	NDC: 71120-611-11	300 mL in 1 CONTAINER; Type 0: Not a Combination Product	01/01/2016

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	01/01/2016

Labeler - Sanit Technologies LLC (075711022)

Establishment
Name	Address	ID/FEI	Business Operations
Lab Express International		800875106	relabel(71120-611) , api manufacture(71120-611) , repack(71120-611)

Establishment
Name	Address	ID/FEI	Business Operations
Organics Corporation of America DBA Ambix Laboratories		061061164	manufacture(71120-611)

Establishment
Name	Address	ID/FEI	Business Operations
Durisan		085479946	manufacture(71120-611)