Handi-Klean 70% Alcohol Hand Sanitizer

Hand Sanitizer by

Drug Labeling and Warnings

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

Drug Details [pdf]

HAND SANITIZER- alcohol liquid 
Solar Chemicals Inc

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Handi-Klean 70% Alcohol Hand Sanitizer

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

HAND SANITIZER 
alcohol liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73831-105
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	72.82 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
TROLAMINE (UNII: 9O3K93S3TK)	0.133 mL  in 100 mL
LAVENDER OIL (UNII: ZBP1YXW0H8)	0.05 mL  in 100 mL
GLYCERIN (UNII: PDC6A3C0OX)	1.21 mL  in 100 mL
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (4500 MPA.S) (UNII: T967IEU43C)	1.74 mL  in 100 mL
WATER (UNII: 059QF0KO0R)	24.047 mL  in 100 mL

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73831-105-01	236.59 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/30/2020	08/01/2020
2	NDC: 73831-105-02	3785.41 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/30/2020	08/01/2020
3	NDC: 73831-105-03	18927 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/30/2020	08/01/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	03/30/2020	08/01/2020

Labeler - Solar Chemicals Inc (030034888)

Registrant - Solar Chemicals Inc (030034888)

Establishment
Name	Address	ID/FEI	Business Operations
Solar Chemicals Inc		030034888	manufacture(73831-105)

Revised: 8/2020

Document Id: ac26196f-5b91-a3f9-e053-2a95a90a4c96

34390-5

Set id: a848b7fe-411d-2c93-e053-2a95a90aec17

Version: 2

Effective Time: 20200805