Cleanette Benalkonium Chloride 0.10% (Deactivated)

Cleanette Antibacterial by

Drug Labeling and Warnings

Cleanette Antibacterial by is a Otc medication manufactured, distributed, or labeled by Harper Hygienics S.A.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

CLEANETTE ANTIBACTERIAL- benzalkonium chloride solution 
Harper Hygienics S.A.

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.

----------

Cleanette Benalkonium Chloride 0.10% (Deactivated)

Drug Facts

Active Ingredient & Purpose

Active ingredientPurpose
Benzalkonium Chloride 0.10% v/v...........................................................................................................................Antiseptic

Uses

Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

Warnings

For external use only.

Do not use

  • on children less than 2 months of age
  • on open skin wounds

When using this product

keep out of eyes, ears and mouth. In case of contact with eyes, rinse eyes thoroughly with water.


Stop use and ask a doctor if

irritation or rash occurs. These may be signs of a serious condition.

Keep out of reach of children.

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

Directions

  • remove a wipe, rub product to cover all surfaces and rub hands together untli dry
  • supervise children under 6 years of age when using this product to avoid swallowing

Other information

  • store between 68-77˚F (20-25˚C)
  • do not expose to excessive heat

TAMPER EVIDENT: Do not use tab seal is open, torn ot missing.

Inactive ingredients

allantoin, citric acid, fragrance, glycerin, phenoxyethanol, polyglyceryl-4 caprate, potassium sorbate, sodium benzoate, tetrasodium glutamate diacetate, water

Questions or comments?

Manufactured & Distributed by:

Harper Hygienics S.A.

Aleje Jerozolimskie 96, Equator II, XIII p.

00-807 Warszawa

tel. +48 25 759 84 00

e-mail: kontakt@harperhygienics.com

Made in Poland

Package Label - Principal Display Panel

Cleanette Antibacterial Hand Sanitizer Wipes 15 count

81333-102-15

15ct Wipes

Cleanette Antibacterial Hand Sanitizer Wipes 24 count

81333-101-24

24ct Wipes

Cleanette Antibacterial Travel Pack Hand Sanitizer Wipes 40 count

81333-100-40

40ct Wipes

Cleanette Antibacterial Family Hand Sanitizer Wipes 60 count

81333-100-60

60ct Wipe

CLEANETTE ANTIBACTERIAL 
benzalkonium chloride solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 81333-100
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE2.43 mg
Inactive Ingredients
Ingredient NameStrength
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
ALLANTOIN (UNII: 344S277G0Z)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
WATER (UNII: 059QF0KO0R)  
GLYCERIN (UNII: PDC6A3C0OX)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
POLYGLYCERYL-4 CAPRATE (UNII: 3N873UN885)  
TETRASODIUM GLUTAMATE DIACETATE (UNII: 5EHL50I4MY)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 81333-100-6060 in 1 BAG; Type 0: Not a Combination Product01/26/202112/31/2021
2NDC: 81333-100-4040 in 1 BAG; Type 0: Not a Combination Product01/26/202112/31/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A01/11/202012/31/2021
CLEANETTE ANTIBACTERIAL 
benzalkonium chloride solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 81333-101
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE2.39 mg
Inactive Ingredients
Ingredient NameStrength
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
ALLANTOIN (UNII: 344S277G0Z)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
WATER (UNII: 059QF0KO0R)  
GLYCERIN (UNII: PDC6A3C0OX)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
POLYGLYCERYL-4 CAPRATE (UNII: 3N873UN885)  
TETRASODIUM GLUTAMATE DIACETATE (UNII: 5EHL50I4MY)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 81333-101-2424 in 1 BAG; Type 0: Not a Combination Product01/26/202112/31/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A01/11/202012/31/2021
CLEANETTE ANTIBACTERIAL 
benzalkonium chloride solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 81333-102
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE1.89 mg
Inactive Ingredients
Ingredient NameStrength
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
ALLANTOIN (UNII: 344S277G0Z)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
WATER (UNII: 059QF0KO0R)  
GLYCERIN (UNII: PDC6A3C0OX)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
POLYGLYCERYL-4 CAPRATE (UNII: 3N873UN885)  
TETRASODIUM GLUTAMATE DIACETATE (UNII: 5EHL50I4MY)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 81333-102-1515 in 1 BAG; Type 0: Not a Combination Product01/26/202112/31/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A01/11/202012/31/2021
Labeler - Harper Hygienics S.A. (422133819)

Revised: 12/2021
Document Id: d460468d-3779-0c52-e053-2995a90acffb
Set id: b9d81dd3-da57-107b-e053-2995a90a0072
Version: 3
Effective Time: 20211230
 
© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.