FDA.reportPublic FDA data

AMORAY 70% ETHYL ALCOHOL HAND SANITIZER ORIGINAL

Product NDC
51628-4437
11-digit product format
516284437
Labeler code
51628
Product ID
51628-4437_1ccb9bb3-07e0-d317-e063-6394a90a0c4d
Type
HUMAN OTC DRUG
Nonproprietary name
Ethyl Alcohol
Dosage form
GEL
Route
TOPICAL
Labeler
MY IMPORTS USA LLC
Application
M003
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-07-08
Substance
ALCOHOL
Active strength
70 mL/100mL
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AMORAY 70% ETHYL ALCOHOL HAND SANITIZER ORIGINALETHYL ALCOHOLMY IMPORTS USA LLC1ccbbc55-3f7d-76d1-e063-6294a90a55902024-07-09WarningsExact identifier

Warnings cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

warnings

Warnings For external use only. Flammable. Keep away from heat, sparks, electrical, fire or flame. Do not apply around eyes. Do not apply around eyes. Do not use in ears & mouth When using this product When using this product, avoid contact with eyes. In case of eye contact remove any contact lenses, and flush eyes with cold water. Call a poison control center or physician. Stop use and seek medical advisement Stop use and seek medical advisement if irritation and redness develop. If swallowed, do not induce vomiting. Seek immediate medical attention. Keep out of reach od children Children must be supervised in use of this product.

Additional Listing Data#

Finished product
Yes
Brand name base
AMORAY 70% ETHYL ALCOHOL HAND SANITIZER ORIGINAL
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ALCOHOL70 mL/100mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii3K9958V90M
Rxcui581662

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51628-4437-1AMORAY 70% ETHYL ALCOHOL HAND SANITIZER ORIGINAL53 mL in 1 BOTTLEGEL531

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51628-4437AMORAY 70% ETHYL ALCOHOL HAND SANITIZER ORIGINAL (ETHYL ALCOHOL) GEL [MY IMPORTS USA LLC]1Current NDC, 1 package rows20240710_1ccbbc55-3f7d-76d1-e063-6294a90a5590.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
581662ethanol 70 % Topical GelPSN1ccbbc55-3f7d-76d1-e063-6294a90a55901
581662ethanol 0.7 ML/ML Topical GelSCD1ccbbc55-3f7d-76d1-e063-6294a90a55901
581662ethanol 70 % Topical GelSY1ccbbc55-3f7d-76d1-e063-6294a90a55901
581662ethyl alcohol 70 % Topical GelSY1ccbbc55-3f7d-76d1-e063-6294a90a55901

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
51628-4437-15162844370153 mL in 1 BOTTLE (51628-4437-1) 53 ml2024-07-08NoNoCurrent