HAN-SAN TOPICAL 80 liquid HAN-SAN GEL gel HAN-SAN TOPICAL liquid

Han-San Gel with Aloe by

Drug Labeling and Warnings

Han-San Gel with Aloe by is a Otc medication manufactured, distributed, or labeled by Rite-Kem Incorporated. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Alcohol 70%

PURPOSE

Antiseptic

INDICATIONS & USAGE

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

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

STOP USE

Stop use and ask a doctor if irritiation or rash occurs. These may be signs of 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 right away.

DOSAGE & ADMINISTRATION

Directions.

• Place enough product on hands to cover all surfaces. Rub together until dry.
• Suerpvise children under 6 years of age when using this product to avoid swallowing.

OTHER SAFETY INFORMATION

Other information

store between 15-30 c (59-86F)

Avoid freezing and excessing heat above 40 c (104F)

INACTIVE INGREDIENT

Inactive ingredients: glycerin, hydrogen peroxide, purified water USP

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

HAN-SAN TOPICAL 80 
han-san topical 80 liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73943-947
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
GLYCERIN (UNII: PDC6A3C0OX)
HYDROGEN PEROXIDE (UNII: BBX060AN9V)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73943-947-01	946 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/24/2020
2	NDC: 73943-947-02	3785 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/24/2020
3	NDC: 73943-947-03	473 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/24/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	03/24/2020

HAN-SAN GEL 
han-san gel gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73943-945
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	70 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)
CARBOMER 940 (UNII: 4Q93RCW27E)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73943-945-01	59.14 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/24/2020
2	NDC: 73943-945-02	1123.79 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/24/2020
3	NDC: 73943-945-03	3785.41 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/24/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	03/24/2020

HAN-SAN TOPICAL 
han-san topical liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73943-946
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	70 mL  in 100 mL

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73943-946-01	946 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/24/2020
2	NDC: 73943-946-02	3785 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/24/2020
3	NDC: 73943-946-03	473 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/24/2020
4	NDC: 73943-946-04	208198 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/24/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	03/24/2020

Labeler - Rite-Kem Incorporated (786892927)

Establishment
Name	Address	ID/FEI	Business Operations
Rite-Kem Incorporated		786892927	manufacture(73943-945, 73943-946, 73943-947)