FDA.reportPublic FDA data

Assured Instant Hand Sanitizer

Manufacturer
Gianthope Arts Product (Huizhou) Company Limited
Effective date
2020-06-02
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:15:35

Label at a glance#

ProductAssured Instant Hand Sanitizer
Active ingredientALCOHOL
Label structure8 sections

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 ingredient

OTC - ACTIVE INGREDIENT SECTION

Ethyl Alcohol 65% 

Purpose

OTC - PURPOSE SECTION

 Antiseptic

Use

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 in ears and mouth.

When using this product

avoid contact with eyes. In case of contact, rinse eyes with water immediately

Stop use and ask a doctor if

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.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Water, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Aminomethyl Propanol, Fragrance

SPL UNCLASSIFIED SECTION

Other information

  • Store between 68-77℉ (20-25℃)
  • May discolor fabrics.

Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage description

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
902574ethanol 65 % Topical GelPSN1
902574ethanol 0.65 ML/ML Topical GelSCD1
902574ethyl alcohol 65 % Topical GelSY1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
78524-002-012022-01-28C16284748780-1d6a99b39-c204-a426-e053-dadaa90af4c22b949b7c-70d9-439e-9dfb-552e2d1b34f0

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
78524-002-01Assured Instant Hand Sanitizer100 mL in 1 BOTTLEGEL1001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
78524-002ASSURED INSTANT HAND SANITIZER (ALCOHOL) GEL [GIANTHOPE ARTS PRODUCT (HUIZHOU) COMPANY LIMITED]1Legacy NDC, 1 package rows20200602_2b949b7c-70d9-439e-9dfb-552e2d1b34f0.zip

Products#

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

DailyMed product names page 1 of 1 · 6 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
78524-00278524-002-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 5 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALCOHOL3K9958V90MACTIB
WATER059QF0KO0RIACT
GLYCERINPDC6A3C0OXIACT
CARBOMER COPOLYMER TYPE A71DD5V995LIACT
AMINOMETHYLPROPANOLLU49E6626QIACT

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
2757a4dc-3414-46e3-a7e3-569a7e86a9712b949b7c-70d9-439e-9dfb-552e2d1b34f02020-06-02WarningsExact identifier
spl id: 2757a4dc-3414-46e3-a7e3-569a7e86a971
spl set id: 2b949b7c-70d9-439e-9dfb-552e2d1b34f0

Reported adverse events (FAERS/openFDA)#

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