HAND SANITIZER - ETHANOL- alcohol liquid 
Benet Incorporated

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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WHO Recommended Hand Sanitizer Formulation - Ethanol

Active Ingredient(s)

Alcohol 80% v/v. Purpose: Antiseptic

Purpose

Antiseptic, Hand Sanitizer

Use

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. Flammable. Keep away from heat or flame

Do not use

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.

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

Other information

Inactive ingredients

glycerin, hydrogen peroxide, purified water USP

Hand Sanitizer - Topical Antiseptic

Hand Sanitizer Label 1 Gallon

Hand Sanitizer 1 GallonHand Sanitizer 1 Quart3785 mL NDC: 76779-0001-1


Hand Sanitizer 1 Gallon.jpg

946 mL NDC: 76779-0001-2

Hand Sanitizer 1 Quart.jpg

HAND SANITIZER - ETHANOL 
alcohol liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76779-0001(NDC:65353-4934)
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL80 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
GLYCERIN (UNII: PDC6A3C0OX) 1.45 mL  in 100 mL
HYDROGEN PEROXIDE (UNII: BBX060AN9V) 0.125 mL  in 100 mL
WATER (UNII: 059QF0KO0R)  
Product Characteristics
Color    Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:76779-0001-13785.4 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/01/2020
2NDC:76779-0001-2946 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/01/2020
3NDC:76779-0001-3473.2 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/01/2020
Image of Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A03/30/2020
Labeler - Benet Incorporated (104989944)
Registrant - Benet Incorporated (104989944)
Establishment
NameAddressID/FEIBusiness Operations
Benet Incorporated104989944repack(76779-0001)

Revised: 4/2020
Document Id: a447fc98-33a5-420c-e053-2995a90aa12b
Set id: a44813aa-f71a-4451-e053-2995a90a0583
Version: 1
Effective Time: 20200427
 
Benet Incorporated