ADVANCED ALCOHOL GEL SANITIZER- alcohol gel 
Betco Corporation, Ltd

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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Advanced Alcohol Gel Sanitizer

Active Ingredient

Active Ingredient

Ethyl Alcohol 70%

Uses

Uses

• Hand sanitizer to reduce microorganisms on the skin.

• Use this product when soap and water are not available.

Purpose

Purpose

Antiseptic

Warnings

Warnings

• For external use only.

• Avoid contact with eyes. If contact occurs, rinse thoroughly with water.

• FLAMMABLE. This product contains ethyl alcohol. Keep away from

sources of ignition.

• Discontinue use if irritation or redness develops.

• If irritation persists for more than 72 hours, consult a physician.

• KEEP OUT OF REACH OF CHILDREN.

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

Directions

Directions

• Read the entire label before using this product.

• Place enough product on your palm to thoroughly cover your hands.

• Rub hands together briskly until dry.

Inactive Ingredients

Inactive Ingredients

Water, PEG/PPG-8/3 Laurate, Gycerin, Carbomer, Tetrahydroxypropylethylendiamine, Fragrance.

Warnings

KEEP OUT OF REACH OF CHILDREN.

Principal Display Panel

AdvancedAlcoholGelSanitizer

ADVANCED ALCOHOL GEL SANITIZER 
alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65601-801
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL0.7 mL  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)  
DIMETHICONE PEG-8 LAURATE (UNII: 72MF9C2A18)  
GLYCERIN (UNII: PDC6A3C0OX)  
EDETOL (UNII: Q4R969U9FR)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:65601-801-19900 mL in 1 BAG; Type 1: Convenience Kit of Co-Package08/01/2019
2NDC:65601-801-291000 mL in 1 BAG; Type 0: Not a Combination Product08/01/2019
3NDC:65601-801-57550 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product08/01/2019
4NDC:65601-801-043780 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product08/01/2019
5NDC:65601-801-55208198 mL in 1 DRUM; Type 0: Not a Combination Product08/01/2019
6NDC:65601-801-991041000 mL in 1 CONTAINER; Type 0: Not a Combination Product07/01/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E08/01/2019
Labeler - Betco Corporation, Ltd (024492831)
Registrant - Betco Corporation, Ltd (024492831)
Establishment
NameAddressID/FEIBusiness Operations
Betco Corporation, Ltd024492831manufacture(65601-801) , label(65601-801)

Revised: 6/2022
Document Id: e077d195-ea35-06f6-e053-2995a90a8b6b
Set id: a23b997c-b010-5985-e053-2995a90aadf3
Version: 7
Effective Time: 20220602
 
Betco Corporation, Ltd