FDA.reportPublic FDA data

MediShield Pro Original Antiseptic Hand Sanitizer

Manufacturer
7327641 Canada, Inc.
Effective date
2021-04-22
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:39:55

Label at a glance#

ProductMediShield Pro Original Antiseptic Hand Sanitizer
Active ingredientALCOHOL
Label structure8 sections

Indications and uses

For hand washing to decrease bacteria on the skin Recommended for repeated use

Dosage and administration

Wet hands thoroughly with product and allow to dry without wiping

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Ethyl alcohol 70%

Purpose

OTC - PURPOSE SECTION

Antiseptic

Uses

INDICATIONS & USAGE SECTION

  • For hand washing to decrease bacteria on the skin
  • Recommended for repeated use

Warnings

WARNINGS SECTION

For external use only
Flammable, keep away from fire or flame

Do not use

OTC - DO NOT USE SECTION

in the eyes

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • irritation and redness develop 
  • condition persists for more than 72 hours

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

Wet hands thoroughly with product and allow to dry without wiping

Other information

SPL UNCLASSIFIED SECTION

  • Avoid temperatures over 110°F (43°C)
  • May discolor certain fabrics
  • Harmful to wood finishes and plastics

Inactive ingredients

INACTIVE INGREDIENT SECTION

Water, glycerin, carbomer, triethanolamine, fragrance, tocopheryl acetate, aloe vera powder

Questions?

OTC - QUESTIONS SECTION

1-877-874-0606, Weekdays, 9AM – 5PM EST

Package Labeling:

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
81818-001-002023-01-30C16284748780-1f386c64a-2c5d-0266-e053-dadaa90a7c1aMediShield Pro Original Antiseptic Hand Sanitizer

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
81818-001-00MediShield Pro Original Antiseptic Hand Sanitizer500 mL in 1 BOTTLEGEL5001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
81818-001MEDISHIELD PRO ORIGINAL ANTISEPTIC HAND SANITIZER (ALCOHOL) GEL [7327641 CANADA, INC.]1Legacy NDC, 1 package rows20210424_c08e9d19-56f1-74e9-e053-2995a90aae5e.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
81818-00181818-001-00

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
GLYCERINPDC6A3C0OXIACT
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE0A5MM307FCIACT
TROLAMINE9O3K93S3TKIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
ALOE VERA LEAFZY81Z83H0XIACT
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
c08e9b3b-ce9d-7f0f-e053-2995a90ae421c08e9d19-56f1-74e9-e053-2995a90aae5e2021-04-22WarningsExact identifier
spl id: c08e9b3b-ce9d-7f0f-e053-2995a90ae421
spl set id: c08e9d19-56f1-74e9-e053-2995a90aae5e

Reported adverse events (FAERS/openFDA)#

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