FDA.reportPublic FDA data

Amoray Premium Hand Sanitizer

Manufacturer
My Imports USA LLC
Effective date
2020-10-14
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-01 23:11:43

Label at a glance#

ProductAmoray Premium Hand Sanitizer
Active ingredientALCOHOL
Label structure7 sections

Indications and uses

•Hand sanitizer to help decrease bacteria on the skin. •When water, soap & towel are not available. •Recommended for repeated use.

Dosage and administration

•Pump as needed into your palms and thoroughly spread on both hands. •Rub into skin until dry.

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Ethyl Alcohol 62%

Purpose

OTC - PURPOSE SECTION

Antiseptic

Uses

INDICATIONS & USAGE SECTION

•Hand sanitizer to help decrease bacteria on the skin. •When water, soap & towel are not available. •Recommended for repeated use.

Warnings

WARNINGS SECTION

For external use only. Flammable. Keep away from fire or flame. Do not apply around eyes.

Do not use

OTC - DO NOT USE SECTION

in ears & mouth.

When using this product,

OTC - WHEN USING SECTION

avoid contact with eyes. In case of contact flush eyes with water.

Stop use and ask a doctor if

OTC - STOP USE SECTION

redness or irritation develop and persist for more than 72 hours.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Children must be supervised in use of this product.

Directions

DOSAGE & ADMINISTRATION SECTION

•Pump as needed into your palms and thoroughly spread on both hands. •Rub into skin until dry.

Other information

SPL UNCLASSIFIED SECTION

•Store at 20°C (68 to 77°F).•May discolor fabrics.

Inactive ingredients

INACTIVE INGREDIENT SECTION

•Water, triethanolamine, glycerin, carbomer, PEG-40 hydrogenated castor oil, propylene glycol, fragrance, tocopheryl acetate, aloe barbadensis gel.

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

BottleBottle

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
51628-4221-02024-11-21C16284748780-11030e365-4086-111a-e063-dadaa90a10e2Amoray Premium Hand Sanitizer
51628-4221-02024-01-30C16284748780-11030e365-4086-111a-e063-dadaa90a10e2Amoray Premium Hand Sanitizer

Products#

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

DailyMed product names page 1 of 1 · 9 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
51628-422151628-4221-0

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
TROLAMINE9O3K93S3TKIACT
GLYCERINPDC6A3C0OXIACT
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE0A5MM307FCIACT
POLYOXYL 40 HYDROGENATED CASTOR OIL7YC686GQ8FIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
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
27645be9-3578-96ee-e063-6394a90a743aabab3301-990c-41cc-e053-2a95a90a29802024-11-20WarningsExact identifier
spl set id: abab3301-990c-41cc-e053-2a95a90a2980

Reported adverse events (FAERS/openFDA)#

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