FOAMING ALCOHOL HAND SANITIZER- alcohol aerosol, foam

Foaming Alcohol Hand Sanitizer by

Drug Labeling and Warnings

Foaming Alcohol Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by Betco Corp, Accra Pac, Inc. (DBA KIK-Indiana). Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

Ethyl Alcohol 62% v/v

Purpose

Antiseptic

Uses

• To help decrease bacterial germs on the sk!in that could cause

disease. For use when soap and water are not available.

• Recommended for repeated use.

Warnings

Warnings
For external use only

Do not puncture or incinerate.

Do not store above 120°F (49°C).

When using this product

Avoid contact with eyes.
It splashed in eyes, rinse immediately and thoroughly with water.
Do not use on chil'dren under 2 months of age.
Do not use on open wounds.
Discontinue use if irritation/redness occurs.

Stop use and ask a physician

Stop use and ask a physician if irritation occurs for more than 3 days, contact a physician.

Keep out of reach of children

In case of ingestion, get medical help or contact a Poison Control Center immediately.

Directions

Shake well before using.

Spray product on hands, enough to cover all surfaces. Rub hands together until all surfaces are wet and fully covered. Continue rubbing untiil hands feel dry. Do not rinse or wipe off sanitizer.

Supervise children under 6 years of age when using this product to avoid swallowing.

Dosage & Administration

Spray product on hands, enough to cover all surfaces. Rub hands together until all surfaces are wet and fully covered. Continue rubbing untiil hands feel dry. Do not rinse or wipe off sanitizer.

Other Information

For best benefit, store and use are 55-85° F (13-29°C).

Inactive Ingredient

Water, Hydrofluorocarbon 152a, lsobutane, Emulsifying Wax., Cetyl Lactate, Steareth-2, Sodium Benzoate, Sodium Sesquicarbonate.
Fragrance

Principal Display Panel

INGREDIENTS AND APPEARANCE

FOAMING ALCOHOL HAND SANITIZER 
alcohol aerosol, foam

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 65601-309
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	63 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
TROLAMINE (UNII: 9O3K93S3TK)
GLYCERIN (UNII: PDC6A3C0OX)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 65601-309-01	1 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/08/2020
2	NDC: 65601-309-02	222 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/08/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	06/08/2020

Labeler - Betco Corp (024492831)

Registrant - Accra Pac, Inc. (DBA KIK-Indiana) (024213616)

Establishment
Name	Address	ID/FEI	Business Operations
Accra Pac, Inc. (DBA KIK-Indiana)		024213616	manufacture(65601-309) , label(65601-309)