Active Ingredient(s)

Ethyl Alcohol 75% v/v. Purpose: Antiseptic

Purpose

Antiseptic

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

on 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

May discolor fabrics or surfaces. Avoid excessive heat. Store below 105F (40C).

Inactive ingredients

Water (Aqua), Tert-Butyl Alcohol, Denatonium Benzoate, Carbomer, Triethanolamine.

Package Label - Principal Display Panel

5000 mL NDC: 77490-075-50

HAND SANITIZER
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:77490-075(NDC:74658-001)
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	75 mL in 100 mL

Ingredient Name	Strength
Inactive Ingredients
DENATONIUM BENZOATE (UNII: 4YK5Z54AT2)	0.0004 mL in 100 mL
CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: HHT01ZNK31)	0.3 mL in 100 mL
TROLAMINE (UNII: 9O3K93S3TK)	0.09 mL in 100 mL
WATER (UNII: 059QF0KO0R)	24.52 mL in 100 mL
TERT-BUTYL ALCOHOL (UNII: MD83SFE959)	0.093 mL in 100 mL

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:77490-075-50	5000 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/15/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	04/15/2020

Labeler - On The Spot Products, LLC (117497833)

Registrant - On The Spot Products, LLC (117497833)

Name	Address	ID/FEI	Business Operations
Establishment
On The Spot Products, LLC		117497833	relabel(77490-075)