This is a hand sanitizer manufactured according to the Temporary Policy for Preparation of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (CoViD-19); Guidance for Industry.

The hand sanitizer is manufactured using only the following United States Pharmacopoeia (USP) grade ingredients in the preparation of the product.

Alcohol (ethanol) (USP or Food Chemical Codex (FCC) grade) (70%, volume/volume (v/v)) in an aqueous solution denatured according to Alcohol and Tobacco Tax and Trade Bureau regulations in 27 CFR part 20.
Glycerin (0.63% v/v).
Carbomer 940 (6.27% v/v)
PEG-8 Dimethicone (0.45% v/v)
Trolamine (0.22% v/v)
East Indian Lemon Grass Oil (0.14% v/v)
Purified Water

The firm does not add other active or inactive ingredients.

Active Ingredient(s)

Alcohol 70% v/v. Purpose: Antiseptic

Purpose

Antiseptic, Hand Sanitizer

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

Carbomer 940, Fragrance, Glycerin, Peg-8 Dimethicone, Trolamine, Water

Package Label - Principal Display Panel

1 Gallon NDC: 74793-0010-6 354 ml NDC: 74793-0010-4 2 L NDC: 74793-0010-5 118 ml NDC: 74793-0010-1 236 ml NDC: 74793-0010-2 251 ml NDC: 74793-0010-3

FASTENAL CLEAN CHOICE
fastenal clean choice gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:74793-0010
Route of Administration	TOPICAL

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

Ingredient Name	Strength
Inactive Ingredients
GLYCERIN (UNII: PDC6A3C0OX)	0.63 mL in 100 mL
EAST INDIAN LEMONGRASS OIL (UNII: UP0M8M3VZW)	0.14 mL in 100 mL
CARBOMER 940 (UNII: 4Q93RCW27E)	6.27 mL in 100 mL
TROLAMINE (UNII: 9O3K93S3TK)	0.22 mL in 100 mL
WATER (UNII: 059QF0KO0R)	22.29 mL in 100 mL
PEG-8 DIMETHICONE (UNII: GIA7T764OD)	0.45 mL in 100 mL

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:74793-0010-1	118 mL in 1 BOTTLE; Type 0: Not a Combination Product	10/16/2020
2	NDC:74793-0010-2	236 mL in 1 BOTTLE; Type 0: Not a Combination Product	10/16/2020
3	NDC:74793-0010-3	251 mL in 1 BOTTLE; Type 0: Not a Combination Product	10/16/2020
4	NDC:74793-0010-4	354 mL in 1 BOTTLE; Type 0: Not a Combination Product	10/16/2020
5	NDC:74793-0010-5	2000 mL in 1 BOTTLE; Type 0: Not a Combination Product	10/16/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	10/16/2020

Labeler - Streamline Polymers LLC (117054225)

Fastenal Clean Choice