FDA.reportPublic FDA data

Medical Sanitizer

Manufacturer
Cedar Medical Llc
Effective date
2020-08-18
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:29:14

Label at a glance#

ProductMedical Sanitizer
Active ingredientALCOHOL
Label structure9 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 the product to avoid swallowing

Storage and handling

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

Label contents#

Full prescribing information#

Active Ingredient(s)

OTC - ACTIVE INGREDIENT SECTION

Alcohol 70% v/v

Purpose

OTC - PURPOSE SECTION

Antiseptic

Use(s)

INDICATIONS & USAGE SECTION

• Health care personnel hand rub to help reduce bacteria that potentially can cause disease

Warnings

WARNINGS SECTION

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 wound

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

Stop use and ask a doctor if irritation occurs. These may be signs of a serious disease.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. 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 the product to avoid swallowing

Other information

STORAGE AND HANDLING SECTION

• Store between 15-30C (59-86F)

• Avoid freezing and excessive heat above 40C (104F)

INACTIVE INGREDIENT SECTION

Inactive ingredients fragrance, glycerin, *hydroxypropyl cellulose, *hydroxypropyl methylcellulose, water

*May or may not include

SPL UNCLASSIFIED SECTION

UNSCENTED HAND GEL

KILLS 99.9% OF GERMS

WHO FORMULA

MADE IN THE USA

EPA APPROVED FACILITY

Distributed By:

Cedar Medical LLC

Tampa, FL, USA

Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PackagingPackaging

PackagingPackaging

PackagingPackaging

PackagingPackaging

PackagingPackaging

PackagingPackaging

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
581662ethanol 70 % Topical GelPSN1
581662ethanol 0.7 ML/ML Topical GelSCD1
581662ethanol 70 % Topical GelSY1
581662ethyl alcohol 70 % Topical GelSY1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
80101-102-042022-01-28C16284748780-1d6a99b39-9558-a426-e053-dadaa90af4c2Medical © SANITIZER
80101-102-082022-01-28C16284748780-1d6a99b39-9558-a426-e053-dadaa90af4c2Medical © SANITIZER
80101-102-102022-01-28C16284748780-1d6a99b39-9558-a426-e053-dadaa90af4c2Medical © SANITIZER
80101-102-162022-01-28C16284748780-1d6a99b39-9558-a426-e053-dadaa90af4c2Medical © SANITIZER
80101-102-322022-01-28C16284748780-1d6a99b39-9558-a426-e053-dadaa90af4c2Medical © SANITIZER
80101-102-602022-01-28C16284748780-1d6a99b39-9558-a426-e053-dadaa90af4c2Medical © SANITIZER

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80101-102-04Medical Sanitizer118 mL in 1 BOTTLEGEL1181
80101-102-08Medical Sanitizer236 mL in 1 BOTTLEGEL2361
80101-102-10Medical Sanitizer3780 mL in 1 BOTTLEGEL37801
80101-102-16Medical Sanitizer473 mL in 1 BOTTLEGEL4731
80101-102-32Medical Sanitizer946 mL in 1 BOTTLEGEL9461
80101-102-60Medical Sanitizer60 mL in 1 BOTTLEGEL601

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80101-102MEDICAL SANITIZER (ALCOHOL) GEL [CEDAR MEDICAL LLC]1Legacy NDC, 6 package rows20200915_aa700141-a367-4b2d-84a9-753600ff197f.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
80101-10280101-102-60, 80101-102-04, 80101-102-08, 80101-102-16, 80101-102-32, 80101-102-10

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 5 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALCOHOL3K9958V90MACTIB
GLYCERINPDC6A3C0OXIACT
HYDROXYPROPYL CELLULOSE, UNSPECIFIED9XZ8H6N6OHIACT
HYPROMELLOSE, UNSPECIFIED3NXW29V3WOIACT
WATER059QF0KO0RIACT

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
1e66bd8c-2582-400a-98eb-31b92e68a5efaa700141-a367-4b2d-84a9-753600ff197f2020-08-18WarningsExact identifier
spl id: 1e66bd8c-2582-400a-98eb-31b92e68a5ef
spl set id: aa700141-a367-4b2d-84a9-753600ff197f

Reported adverse events (FAERS/openFDA)#

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