FDA.reportPublic FDA data

AMOUAGE Sanitizer Gel

Manufacturer
AMOUAGE SAOC
Effective date
2021-11-10
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:44:52

Label at a glance#

ProductAMOUAGE
Active ingredientALCOHOL
Label structure12 sections

Dosage and administration

Put enough product in your palm to cover hands and rub hands together briskly until dry Supervise children under 6 years of age when using this product to avoid swallowing.

Storage and handling

Avoid freezing and excessive heat above 40C (104F) May discolor certain fabrics or surfaces

Label contents#

Full prescribing information#

Active Ingredient(s)

OTC - ACTIVE INGREDIENT SECTION

Alcohol 70% v/v. Purpose: Antiseptic

Purpose

OTC - PURPOSE SECTION

Antiseptic, Hand Sanitizer

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

Do not use

OTC - DO NOT USE SECTION

  • in children less than 2 months of age
  • on open skin wounds

OTC - WHEN USING SECTION

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 doctor if irritation or rash occurs. These may be signs of a serious condition.
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

OTC - STOP USE SECTION

Stop use and ask a doctor if 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

  • Put enough product in your palm to cover hands and rub hands together briskly until dry
  • Supervise children under 6 years of age when using this product to avoid swallowing.

Other information

STORAGE AND HANDLING SECTION

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

May discolor certain fabrics or surfaces

Inactive ingredients

INACTIVE INGREDIENT SECTION

alpha-isomethyl ionone, carbopol aqua sf-1, citronellol, eugenol, geraniol, glycerin, hydroxycitronellal, rose (as parfum), sodium hydroxide, purified water

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

60 mL NDC:79809-111-1160 mL NDC:79809-111-11

60 mL NDC:79809-111-11

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
581662ethanol 70 % Topical GelPSN2
581662ethanol 0.7 ML/ML Topical GelSCD2
581662ethanol 70 % Topical GelSY2
581662ethyl alcohol 70 % Topical GelSY2

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
79809-111-112023-01-30C16284748780-1f386c649-f5e2-0266-e053-dadaa90a7c1aAMOUAGE Sanitizer Gel
79809-111-122023-01-30C16284748780-1f386c649-f5e2-0266-e053-dadaa90a7c1aAMOUAGE Sanitizer Gel
79809-111-132023-01-30C16284748780-1f386c649-f5e2-0266-e053-dadaa90a7c1aAMOUAGE Sanitizer Gel

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
79809-111-11AMOUAGE60 mL in 1 BOTTLEGEL602
79809-111-12AMOUAGE300 mL in 1 BOTTLEGEL3002
79809-111-13AMOUAGE120 mL in 1 BOX, UNIT-DOSEGEL1202

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
79809-111AMOUAGE (SANITIZER GEL) GEL [AMOUAGE SAOC]2Legacy NDC, 3 package rows20211111_af8750ca-a9c9-5d0f-e053-2995a90a5a7d.zip

Products#

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

DailyMed product names page 1 of 1 · 13 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
79809-11179809-111-11, 79809-111-12, 79809-111-13

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Name, UNII, Kind table
NameUNIIKind
.BETA.-CITRONELLOL, (R)-P01OUT964KIACT
ROSE OILWUB68Y35M7IACT
HYDROXYCITRONELLAL8SQ0VA4YURIACT
GERANIOLL837108USYIACT
EUGENOL3T8H1794QWIACT
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (4500 MPA.S)T967IEU43CIACT
GLYCERINPDC6A3C0OXIACT
SODIUM HYDROXIDE55X04QC32IIACT
WATER059QF0KO0RIACT
ALCOHOL3K9958V90MACTIB
ISOMETHYL-.ALPHA.-IONONE9XP4LC555BIACT

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
d06fc376-3f2f-b30e-e053-2a95a90a414aaf8750ca-a9c9-5d0f-e053-2995a90a5a7d2021-11-10WarningsExact identifier
spl id: d06fc376-3f2f-b30e-e053-2a95a90a414a
spl set id: af8750ca-a9c9-5d0f-e053-2995a90a5a7d

Reported adverse events (FAERS/openFDA)#

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