ADVANCED ALCOHOL GEL SANITIZER- alcohol gel

Advanced Alcohol Gel Sanitizer by

Drug Labeling and Warnings

Advanced Alcohol Gel Sanitizer by is a Otc medication manufactured, distributed, or labeled by Betco Corporation, Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

INGREDIENTS AND APPEARANCE

ADVANCED ALCOHOL GEL SANITIZER 
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 65601-801
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	0.7 mL  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 65601-801-19	900 mL in 1 BAG; Type 1: Convenience Kit of Co-Package	08/01/2019
2	NDC: 65601-801-29	1000 mL in 1 BAG; Type 0: Not a Combination Product	08/01/2019
3	NDC: 65601-801-57	550 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	08/01/2019
4	NDC: 65601-801-04	3780 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	08/01/2019
5	NDC: 65601-801-55	208198 mL in 1 DRUM; Type 0: Not a Combination Product	08/01/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	08/01/2019

Labeler - Betco Corporation, Ltd (024492831)

Registrant - Betco Corporation, Ltd (024492831)

Establishment
Name	Address	ID/FEI	Business Operations
Betco Corporation, Ltd		024492831	manufacture(65601-801) , label(65601-801)