FDA.reportPublic FDA data

AMORAY 70% ETHYL ALCOHOL HAND SANITIZER STRAWBERRY

Product NDC
51628-4438
11-digit product format
516284438
Labeler code
51628
Product ID
51628-4438_1ccb93e9-9973-20ed-e063-6294a90a7997
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 STRAWBERRYETHYL ALCOHOLMY IMPORTS USA LLC1ccbc68e-2b6b-768c-e063-6294a90a643b2024-07-09WarningsExact 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 STRAWBERRY
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
51628-4438-1AMORAY 70% ETHYL ALCOHOL HAND SANITIZER STRAWBERRY53 mL in 1 BOTTLEGEL531

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51628-4438AMORAY 70% ETHYL ALCOHOL HAND SANITIZER STRAWBERRY (ETHYL ALCOHOL) GEL [MY IMPORTS USA LLC]1Current NDC, 1 package rows20240710_1ccbc68e-2b6b-768c-e063-6294a90a643b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
581662ethanol 70 % Topical GelPSN1ccbc68e-2b6b-768c-e063-6294a90a643b1
581662ethanol 0.7 ML/ML Topical GelSCD1ccbc68e-2b6b-768c-e063-6294a90a643b1
581662ethanol 70 % Topical GelSY1ccbc68e-2b6b-768c-e063-6294a90a643b1
581662ethyl alcohol 70 % Topical GelSY1ccbc68e-2b6b-768c-e063-6294a90a643b1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
51628-4438-15162844380153 mL in 1 BOTTLE (51628-4438-1) 53 ml2024-07-08NoNoCurrent