FDA.reportPublic FDA data

Shield-EX hand sanitizer

Manufacturer
AMEMed
Effective date
2020-10-01
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:30:52

Label at a glance#

ProductShield-EX hand sanitizer
Active ingredientALCOHOL
Label structure6 sections

Dosage and administration

Wet hands thoroughly with product and rub hands together until dry. For children under 6, use only under adult supervision. Not recommended for infants. Other information Flammable, do not store above 40 °C. May discolor some fabrics. May be harmful to wood finishes and plastic.

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Ethanol Alchohol 70%

Use

INDICATIONS & USAGE SECTION

To decrease bacteria on the skin that could cause disease. Recommended for repeated use.

Warnings

WARNINGS SECTION

For External Use Only - hands.

Ask a doctor if (a) irritation & redness develop or (b) condition persists for more than 72 hours.

Caution: Keep out of reach of children. Avoid contact with mucus membrane, harmful if swallowed.

Stop use and ask a doctor if skin irritation develops.

Directions

DOSAGE & ADMINISTRATION SECTION

  • Wet hands thoroughly with product and rub hands together until dry.
  • For children under 6, use only under adult supervision.
  • Not recommended for infants.

Other information

Flammable, do not store above 40 °C.
May discolor some fabrics. May be harmful to wood finishes and plastic.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Purified Water, Carbomer, lsopropanol, Glycerin, Aloe Barbadansis leaf Juice, Tocopherol (Vitamin E), lsopropyl Myiristate, Diisopropyl Sebacate, Propylene glycol, Aminomethyl Propanol, Fragrance Yellow 5, Blue 1.

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LabelLabel

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
80736-001-012022-01-28C16284748780-1d6a99b39-47af-a426-e053-dadaa90af4c28413ac58-fa0a-4e95-b2b2-e5e64f42088e
80736-001-022022-01-28C16284748780-1d6a99b39-47af-a426-e053-dadaa90af4c28413ac58-fa0a-4e95-b2b2-e5e64f42088e
80736-001-032022-01-28C16284748780-1d6a99b39-47af-a426-e053-dadaa90af4c28413ac58-fa0a-4e95-b2b2-e5e64f42088e
80736-001-042022-01-28C16284748780-1d6a99b39-47af-a426-e053-dadaa90af4c28413ac58-fa0a-4e95-b2b2-e5e64f42088e
80736-001-052022-01-28C16284748780-1d6a99b39-47af-a426-e053-dadaa90af4c28413ac58-fa0a-4e95-b2b2-e5e64f42088e
80736-001-062022-01-28C16284748780-1d6a99b39-47af-a426-e053-dadaa90af4c28413ac58-fa0a-4e95-b2b2-e5e64f42088e
80736-001-072022-01-28C16284748780-1d6a99b39-47af-a426-e053-dadaa90af4c28413ac58-fa0a-4e95-b2b2-e5e64f42088e

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80736-001-01Shield-EX hand sanitizer80 mL in 1 BOTTLE, PLASTICGEL801
80736-001-02Shield-EX hand sanitizer100 mL in 1 BOTTLE, PLASTICGEL1001
80736-001-03Shield-EX hand sanitizer250 mL in 1 BOTTLE, PLASTICGEL2501
80736-001-04Shield-EX hand sanitizer500 mL in 1 BOTTLE, PLASTICGEL5001
80736-001-05Shield-EX hand sanitizer900 mL in 1 BOTTLE, PLASTICGEL9001
80736-001-06Shield-EX hand sanitizer1000 mL in 1 BOTTLE, PLASTICGEL10001
80736-001-07Shield-EX hand sanitizer5000 mL in 1 BOTTLE, PLASTICGEL50001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80736-001SHIELD-EX HAND SANITIZER (ALCOHOL) GEL [AMEMED]1Legacy NDC, 7 package rows20201003_8413ac58-fa0a-4e95-b2b2-e5e64f42088e.zip

Products#

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

DailyMed product names page 1 of 1 · 15 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
80736-00180736-001-01, 80736-001-02, 80736-001-03, 80736-001-04, 80736-001-05, 80736-001-06, 80736-001-07

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 14 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALCOHOL3K9958V90MACTIB
WATER059QF0KO0RIACT
CARBOMER HOMOPOLYMER TYPE C4Q93RCW27EIACT
ISOPROPYL ALCOHOLND2M416302IACT
GLYCERINPDC6A3C0OXIACT
ALOE VERA LEAFZY81Z83H0XIACT
TOCOPHEROLR0ZB2556P8IACT
ISOPROPYL MYRISTATE0RE8K4LNJSIACT
DIISOPROPYL SEBACATEJ8T3X564IHIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
AMINOMETHYLPROPANOLLU49E6626QIACT
FRAGRANCE CLEAN ORC0600327329LCV5BTFIACT
FD&C YELLOW NO. 5I753WB2F1MIACT
FD&C BLUE NO. 1H3R47K3TBDIACT

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
ca04537a-76bd-492f-b102-754d964cf18e8413ac58-fa0a-4e95-b2b2-e5e64f42088e2020-10-01WarningsExact identifier
spl id: ca04537a-76bd-492f-b102-754d964cf18e
spl set id: 8413ac58-fa0a-4e95-b2b2-e5e64f42088e

Reported adverse events (FAERS/openFDA)#

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