Active Ingredient(s)

Ethanol 70% v/v.

Purpose

Topical Antimicrobial

Use

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

When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.
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. If swallowed, get medical help or contact a Poison Control Center right away.

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. If swallowed, get medical help or contact a Poison Control Center right away.

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 information

Store between 15-30C (59-86F)
Avoid freezing and excessive heat above 40C (104F)

Inactive ingredients

water, glycerin, acrylate copolymer, fragrance

Package Label - Principal Display Panel

label

HAND SANITIZER
alcohol liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:73831-106(NDC:78211-003)
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	67.69 mL in 100 mL

Ingredient Name	Strength
Inactive Ingredients
TROLAMINE (UNII: 9O3K93S3TK)	0.175 mL in 100 mL
LAVENDER OIL (UNII: ZBP1YXW0H8)	0.058 mL in 100 mL
GLYCERIN (UNII: PDC6A3C0OX)	1.776 mL in 100 mL
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (4500 MPA.S) (UNII: T967IEU43C)	2.225 mL in 100 mL
WATER (UNII: 059QF0KO0R)	28.076 mL in 100 mL

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:73831-106-01	236.59 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/30/2020
2	NDC:73831-106-02	3785.41 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/30/2020
3	NDC:73831-106-03	18927 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/30/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	03/30/2020

Labeler - Solar Chemicals Inc (030034888)

Registrant - Solar Chemicals Inc (030034888)

Name	Address	ID/FEI	Business Operations
Establishment
Solar Chemicals Inc		030034888	repack(73831-106)

Name	Address	ID/FEI	Business Operations
Establishment
INDUSTRIAL CHEMICALS INC.		113389170	manufacture(73831-106)

Handi-Klean 70% Alcohol Hand Sanitizer