HAND SANITIZER- ethanol gel

Hand Sanitizer by

Drug Labeling and Warnings

Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by Fifth Generation, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Ethanol 80% v/v

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 irritation or rash occurs. These may be signs 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 right away.

DOSAGE & ADMINISTRATION

Directions:

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

OTHER SAFETY INFORMATION

Other Information:

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

Avoid freezing and excessive heat above 40 C (104F)

INACTIVE INGREDIENT

Inactive ingredients glycerin, hydrogen peroxide, purified water USP

Hand Sanitizer

200 mL 73982-000-01

100 mL 73982-000-00

375 mL 73982-000-02

3785 mL 73982-000-03

11356mL 73982-000-04

18927 mL 73982-000-05

208197 mL 73982-000-06

INGREDIENTS AND APPEARANCE

HAND SANITIZER 
ethanol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73982-000
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)
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
TERT-BUTYL ALCOHOL (UNII: MD83SFE959)
DENATONIUM BENZOATE (UNII: 4YK5Z54AT2)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73982-000-01	200 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/27/2020
2	NDC: 73982-000-00	100 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/27/2020
3	NDC: 73982-000-02	375 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/27/2020
4	NDC: 73982-000-03	3785 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/27/2020
5	NDC: 73982-000-04	11356 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/27/2020
6	NDC: 73982-000-05	18927 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/27/2020
7	NDC: 73982-000-06	208197 mL in 1 DRUM; 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

Labeler - Fifth Generation, Inc. (961445723)

Establishment
Name	Address	ID/FEI	Business Operations
Fifth Generation, Inc.		961445723	manufacture(73982-000)