Antiseptic Hand Sanitizer

Antiseptic Hand Sanitizer by

Drug Labeling and Warnings

Antiseptic Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by Canadian Liquids Processors Limited. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ANTISEPTIC HAND SANITIZER- alcohol spray 
Canadian Liquids Processors Limited

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

Drug Facts

Active ingredient

Ethyl alcohol 80%

Purpose

Antiseptic

Use

For hand washing to decrease bacteria on the skin.

Warnings

For external use only.

Flammable, keep away from fire or flame.

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 and allow to dry without wiping.

Inactive ingredients

Citric Acid, denatonium benzoate, FD&C yellow no.5, glycerin, hydrogen peroxide, propylene glycol, sodium benzoate, water.

Questions or Comments?

810-667-4885

Package Labeling:

label

Package Labeling:80691-001-02

Bottle

ANTISEPTIC HAND SANITIZER 
alcohol spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 80691-001
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL0.8 mL  in 1 mL
Inactive Ingredients
Ingredient NameStrength
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
DENATONIUM BENZOATE (UNII: 4YK5Z54AT2)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
GLYCERIN (UNII: PDC6A3C0OX)  
HYDROGEN PEROXIDE (UNII: BBX060AN9V)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 80691-001-01500 mL in 1 BOTTLE; Type 0: Not a Combination Product10/01/202012/22/2021
2NDC: 80691-001-024000 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product02/01/202112/22/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E10/01/202012/22/2021
Labeler - Canadian Liquids Processors Limited (249855933)
Establishment
NameAddressID/FEIBusiness Operations
Canadian Liquids Processors Limited249855933manufacture(80691-001)

Revised: 12/2021
Document Id: d4247926-5c3a-c56c-e053-2a95a90a1c34
Set id: b0b46560-6382-6cc3-e053-2a95a90add75
Version: 3
Effective Time: 20211227