AMERICAN DENTAL- touch hand sanitizer solution

American Dental by

Drug Labeling and Warnings

American Dental by is a Otc medication manufactured, distributed, or labeled by Nutrix International, LLC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient[s]

Alcohol 80%v/v

Purpose

Antiseptic

Use[s]

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

When using this product keep out of eyes, ears, mouth. In case of contact with eyes, rinse 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.

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

Inactive Ingredients

Glycerin, Hydrogen Peroxide, Purified water USP

Package

Front Label

INGREDIENTS AND APPEARANCE

AMERICAN DENTAL 
touch hand sanitizer solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73333-473
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	0.8334 g  in 473 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)	0.14845 g  in 473 g
GLYCERIN (UNII: PDC6A3C0OX)	0.0145 g  in 473 g
HYDROGEN PEROXIDE (UNII: BBX060AN9V)	0.00365 g  in 473 g

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73333-473-01	473 g in 1 BOTTLE; Type 0: Not a Combination Product	05/21/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	05/21/2020

Labeler - Nutrix International, LLC. (117341868)

Establishment
Name	Address	ID/FEI	Business Operations
Nutrix International, LLC.		117341868	manufacture(73333-473) , pack(73333-473) , label(73333-473)