FDA.reportPublic FDA data

Amoveo Original

Manufacturer
Protair-X Health Solutions Inc.
Effective date
2017-02-24
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:48:59

Label at a glance#

ProductAmoveo Original
Active ingredientALCOHOL
Label structure8 sections

Indications and uses

For handwashing 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

Alcohol 80%

Purpose

OTC - PURPOSE SECTION

Antiseptic

Uses

INDICATIONS & USAGE SECTION

  • For handwashing 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
  • may discolor certain fabrics
  • harmful to wood finishes and plastics

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Aloe Vera, Carbomer, Fragrance, Glycerin, Tocopheryl Acetate, Triethanolamine, Water

Questions?

OTC - QUESTIONS SECTION

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

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label2Label2

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
49955-701-012023-01-30C16284748780-1f386c64a-0bdd-0266-e053-dadaa90a7c1aAmoveo Original
49955-701-502023-01-30C16284748780-1f386c64a-0bdd-0266-e053-dadaa90a7c1aAmoveo Original

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49955-701-01Amoveo Original1000 mL in 1 BOTTLEGEL10001
49955-701-50Amoveo Original500 mL in 1 BOTTLEGEL5001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49955-701AMOVEO ORIGINAL (ALCOHOL) GEL [PROTAIR-X HEALTH SOLUTIONS INC.]1Legacy NDC, 2 package rows20170301_494b48be-e237-332f-e054-00144ff88e88.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
49955-70149955-701-50, 49955-701-01

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
ALOE VERA LEAFZY81Z83H0XIACT
CARBOXYPOLYMETHYLENE0A5MM307FCIACT
GLYCERINPDC6A3C0OXIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
TROLAMINE9O3K93S3TKIACT
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
494b48be-e238-332f-e054-00144ff88e88494b48be-e237-332f-e054-00144ff88e882017-02-24WarningsExact identifier
spl id: 494b48be-e238-332f-e054-00144ff88e88
spl set id: 494b48be-e237-332f-e054-00144ff88e88

Reported adverse events (FAERS/openFDA)#

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