FDA.reportPublic FDA data

University Medical PHARMACEUTICALS HAND SANITIZER

Manufacturer
University Medical Pharmaceuticals Corp.
Effective date
2020-05-09
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:10:30

Label at a glance#

ProductUniversity Medical PHARMACEUTICALS HAND 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 this product to avoid swallowing.

Storage and handling

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

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Alcohol 70% v/v

Purpose

OTC - PURPOSE SECTION

Antiseptic

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

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

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 this product to avoid swallowing.

Other information

STORAGE AND HANDLING SECTION

■ Store between 15-30°C (59-86°F)

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

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Aminomethyl Propanol, Glycerin, Tocopheryl Acetate, Purified Water.

SPL UNCLASSIFIED SECTION

NEW

REDUCE BACTERIA THAT POTENTIALLY CAUSE DISEASE

KEEPS HANDS FEELING FRESH AND SOFT

Questions? Call toll free 855-299-8800

Distributed by UNIVERSITY MEDICAL PHARMACEUTICALS CORP
universitymedical.com | 9671 Irvine Center Drive, Irvine, CA 92618

©2020 All rights reserved. Made in USA.

Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage description

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
582753ethanol 70 % Topical SolutionPSN2
582753ethanol 0.7 ML/ML Topical SolutionSCD2
582753ethanol 70 % Topical SolutionSY2
582753ethyl alcohol 70 % Topical SolutionSY2

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50544-888-082022-01-28C16284748780-1d6a99b39-7119-a426-e053-dadaa90af4c2University Medical PHARMACEUTICALS ® HAND SANITIZER

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50544-888-08University Medical PHARMACEUTICALS HAND SANITIZER236 mL in 1 BOTTLE, PLASTICLIQUID2362

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50544-888UNIVERSITY MEDICAL PHARMACEUTICALS HAND SANITIZER (ALCOHOL) LIQUID [UNIVERSITY MEDICAL PHARMACEUTICALS CORP.]2Legacy NDC, 1 package rows20200510_1f436b1e-fd38-4546-bcf4-e61df9904d02.zip

Products#

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

DailyMed product names page 1 of 1 · 7 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
50544-88850544-888-08

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 6 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALCOHOL3K9958V90MACTIB
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED)59TL3WG5COIACT
AMINOMETHYLPROPANOLLU49E6626QIACT
GLYCERINPDC6A3C0OXIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
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
84c91aad-1620-487e-a6b1-8c188df68a751f436b1e-fd38-4546-bcf4-e61df9904d022020-05-09WarningsExact identifier
spl id: 84c91aad-1620-487e-a6b1-8c188df68a75
spl set id: 1f436b1e-fd38-4546-bcf4-e61df9904d02

Reported adverse events (FAERS/openFDA)#

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