American Dental

Manufacturer
Nutrix International, LLC.
Effective date
2020-05-21
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:14:13

Label at a glance#

ProductAmerican Dental
Active ingredientALCOHOL
Label structure12 sections

Dosage and administration

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.

Label contents#

Full prescribing information#

Active Ingredient[s]

OTC - ACTIVE INGREDIENT SECTION

Full LabelFull LabelAlcohol 80%v/v

Purpose

OTC - PURPOSE SECTION

Drug Fact PanelDrug Fact PanelAntiseptic

Use[s]

INDICATIONS & USAGE SECTION

Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

Warnings

WARNINGS SECTION

For external use only. Flammable. Keep away from heat or flame.

Do not use

OTC - DO NOT USE SECTION

  • On children less than 2 months of age.
  • On open skin wounds

When using

OTC - WHEN USING SECTION

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

OTC - STOP USE SECTION

If irritation or rash occurs. These may be signs of a serious condition.

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

  • 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

OTHER SAFETY INFORMATION

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

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Glycerin, Hydrogen Peroxide, Purified water USP

Package

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LabelLabelFront Label

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
73333-473-012022-01-28C16284748780-1d6a99b39-a73f-a426-e053-dadaa90af4c2a62e10a0-12c1-a429-e053-2a95a90ae11e

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
73333-473-01American Dental473 g in 1 BOTTLESOLUTION4731

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
73333-473AMERICAN DENTAL (TOUCH HAND SANITIZER) SOLUTION [NUTRIX INTERNATIONAL, LLC.]1Legacy NDC, 1 package rows20200522_a62e10a0-12c1-a429-e053-2a95a90ae11e.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 6 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
73333-47373333-473-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 4 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
a62dfde4-0773-19d1-e053-2995a90ac5f6a62e10a0-12c1-a429-e053-2a95a90ae11e2020-05-21WarningsExact identifier
spl id: a62dfde4-0773-19d1-e053-2995a90ac5f6
spl set id: a62e10a0-12c1-a429-e053-2a95a90ae11e

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.