FDA.reportPublic FDA data

University of Michigan

Manufacturer
Double Body Biotech Limited
Effective date
2020-07-08
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:20:39

Label at a glance#

ProductUniversity of Michigan
Active ingredientALCOHOL
Label structure11 sections

Dosage and administration

Wet hands thoroughly with gel, rub vigorously and allow to dry without wiping. Children under 6 years of age should be supervised when using this product.

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Alcohol 75%

Purpose

OTC - PURPOSE SECTION

Antiseptic

Use

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.

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.

Do not use

OTC - DO NOT USE SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

  • Wet hands thoroughly with gel, rub vigorously and allow to dry without wiping.
  • Children under 6 years of age should be supervised when using this product.

Other information

OTHER SAFETY INFORMATION

  • Store below 106 F(41℃)

Inactive ingredients

INACTIVE INGREDIENT SECTION

Water, Glycereth-26, Carbomer, Sodium Hydroxide, Aloe Barbadensis Leaf Extract

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

labellabel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1305100ethanol 75 % Topical GelPSN1
1305100ethanol 0.75 ML/ML Topical GelSCD1
1305100ethanol 75 % Topical GelSY1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
74657-016-012022-01-28C16284748780-1d6a99b39-5cd1-a426-e053-dadaa90af4c2University of Michigan Hand Sanitizer

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
74657-016-01University of Michigan59 mL in 1 BOTTLEGEL591

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
74657-016UNIVERSITY OF MICHIGAN (HAND SANITIZER) GEL [DOUBLE BODY BIOTECH LIMITED]1Legacy NDC, 1 package rows20200709_a9ea0361-fa89-fb3a-e053-2995a90ab94d.zip

Products#

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

DailyMed product names page 1 of 1 · 8 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
74657-01674657-016-01

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
SODIUM HYDROXIDE55X04QC32IIACT
GLYCERETH-26NNE56F2N14IACT
CARBOMER 9804Q93RCW27EIACT
ALOE VERA LEAFZY81Z83H0XIACT
WATER059QF0KO0RIACT
ALCOHOL3K9958V90MACTIB

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
a9ea0361-fa8a-fb3a-e053-2995a90ab94da9ea0361-fa89-fb3a-e053-2995a90ab94d2020-07-08WarningsExact identifier
spl id: a9ea0361-fa8a-fb3a-e053-2995a90ab94d
spl set id: a9ea0361-fa89-fb3a-e053-2995a90ab94d

Reported adverse events (FAERS/openFDA)#

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