HAND SANITZER- alcohol solution

Hand Sanitzer by

Drug Labeling and Warnings

Hand Sanitzer by is a Otc medication manufactured, distributed, or labeled by Union Carbide Corporation, The Dow Chemical Company, Dow Chemical Company, Dow Silicones Corporation. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

WARNINGS

For external use only. Flammable. Keep away from heat or flame.

ACTIVE INGREDIENT

Active Ingredient[s] Purpose

Alcohol 80% v/v ........................................................................................................ Anitseptic

DO NOT USE

Do not use

• in children less than 2 months of age
• on open skin wounds

WHEN USING

When using this product, keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.

STOP USE

Stop use and ask a doctor if irritation or rash occurs. this may be a sign of a serious condition.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately.

INACTIVE INGREDIENT

Glycerin, hydrogen peroxide, purified water USP.

DOSAGE & ADMINISTRATION

Directions

• place enough product on hands to cover all surfaces. Rub hands together until dry.
• Supervise Children under 6 years of age to prevent swallowing.

INDICATIONS & USAGE

Use(s)

Hand sanitizer to help reduce bacteria that can cause disease. For use when soap and water are not available.

PURPOSE

Hand sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

HAND SANITZER 
alcohol solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 59044-1006
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	80 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
HYDROGEN PEROXIDE (UNII: BBX060AN9V)
GLYCERIN (UNII: PDC6A3C0OX)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 59044-1006-1	355 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/10/2020
2	NDC: 59044-1006-2	473.125 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/10/2020
3	NDC: 59044-1006-3	946.25 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/10/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	03/27/2020

HAND SANITZER 
alcohol solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 59044-1005
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	80 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
HYDROGEN PEROXIDE (UNII: BBX060AN9V)
GLYCERIN (UNII: PDC6A3C0OX)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 59044-1005-1	3785 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/10/2020
2	NDC: 59044-1005-2	18925 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/10/2020
3	NDC: 59044-1005-3	946.25 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/10/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	03/27/2020

HAND SANITZER 
alcohol solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 59044-1001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	80 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
HYDROGEN PEROXIDE (UNII: BBX060AN9V)
GLYCERIN (UNII: PDC6A3C0OX)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 59044-1001-1	189500 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/27/2020
2	NDC: 59044-1001-2	189500 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/27/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	03/27/2020

HAND SANITZER 
alcohol solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 59044-1002
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	80 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
HYDROGEN PEROXIDE (UNII: BBX060AN9V)
GLYCERIN (UNII: PDC6A3C0OX)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 59044-1002-1	1800 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/27/2020
2	NDC: 59044-1002-2	1800 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/27/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	03/27/2020

HAND SANITZER 
alcohol solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 59044-1003
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	80 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
HYDROGEN PEROXIDE (UNII: BBX060AN9V)
GLYCERIN (UNII: PDC6A3C0OX)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 59044-1003-1	3785 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/27/2020
2	NDC: 59044-1003-2	3785 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/27/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	03/27/2020

HAND SANITZER 
alcohol solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 59044-1004
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	80 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
HYDROGEN PEROXIDE (UNII: BBX060AN9V)
GLYCERIN (UNII: PDC6A3C0OX)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 59044-1004-1	3785 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/09/2020
2	NDC: 59044-1004-2	18925 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/09/2020
3	NDC: 59044-1004-3	1892.5 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/09/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	03/27/2020

HAND SANITZER 
alcohol solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 59044-1007
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	80 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
HYDROGEN PEROXIDE (UNII: BBX060AN9V)
GLYCERIN (UNII: PDC6A3C0OX)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 59044-1007-1	3785 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/10/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	03/27/2020

Labeler - Union Carbide Corporation (001289008)

Establishment
Name	Address	ID/FEI	Business Operations
Union Carbide Corporation		001005623	repack(59044-1004)

Establishment
Name	Address	ID/FEI	Business Operations
The Dow Chemical Company		008092793	repack(59044-1007)

Establishment
Name	Address	ID/FEI	Business Operations
The Dow Chemical Company		008187080	repack(59044-1006)

Establishment
Name	Address	ID/FEI	Business Operations
Dow Chemical Company		053799255	repack(59044-1005)

Establishment
Name	Address	ID/FEI	Business Operations
Union Carbide Corporation		084948483	manufacture(59044-1001)

Establishment
Name	Address	ID/FEI	Business Operations
Dow Silicones Corporation		615225588	manufacture(59044-1002)

Establishment
Name	Address	ID/FEI	Business Operations
Union Carbide Corporation		801038019	manufacture(59044-1003)