FDA.reportPublic FDA data

SaniHands GEL HAND SANITIZER

Manufacturer
Dynasty Chemical Corp.
Effective date
2020-11-17
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:34:16

Label at a glance#

ProductSaniHands Gel Hand Sanitizer
Active ingredientALCOHOL
Label structure9 sections

Dosage and administration

• Place enough product in your palm to thoroughly cover your hands  • Rub hands together briskly until dry • Children under 6 years of age should be supervised when using this product to avoid swallowing.

Storage and handling

• Store between 15-30 C (59-86 F) • Avoid freezing and excessive heat above 40 C (104 F)

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Ethyl Alcohol 65% v/v

Purpose

OTC - PURPOSE SECTION

Sanitary Cleaning

Use

INDICATIONS & USAGE SECTION

Hand santizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

Warnings

WARNINGS SECTION

External use only. Flammable. Keep away from heat or flame.

Do not use

• on children less than 2 months of age

• on open skin wounds

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.

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

• Place enough product in your palm to thoroughly cover your hands 

• Rub hands together briskly until dry

• Children under 6 years of age should be supervised when using this product to avoid swallowing.

Other Information

STORAGE AND HANDLING SECTION

• Store between 15-30 C (59-86 F)

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

Inactive ingredients:

INACTIVE INGREDIENT SECTION

Water, Polyethylene Glycol, Glycerin USP, Hydrogen Peroxide, Acrylate Polymer, Denatorium Benzoate, Lemon Fragrance

SPL UNCLASSIFIED SECTION

CONTAINS MINIMUM 65% ALCOHOL

Leaves Hands Feeling Soft

DIRECTIONS FOR USE

Place enough product in your palm to thoroughly cover your hands. Rub hands together briskly until dry. Children under 6 years of age should be supervised when using this product. Store between 59-86 degrees F (15-30 degrees C). May discolor certain fabrics or surfaces.

KEEP OUT OF REACH OF CHILDREN

For Emergencies, Call 24hr ChemTel: 800-255-3924

REORDER FROM:

DYNASTY CHEMICAL CORP.

444 N.PEARL ST. • ALBANY, NY 12204

TO REORDER CALL: 518-463-1146

Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PackagingPackaging

PackagingPackaging

PackagingPackaging

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
80497-001-012022-01-28C16284748780-1d6a99b39-b4ad-a426-e053-dadaa90af4c2SaniHands GEL HAND SANITIZER
80497-001-022022-01-28C16284748780-1d6a99b39-b4ad-a426-e053-dadaa90af4c2SaniHands GEL HAND SANITIZER
80497-001-032022-01-28C16284748780-1d6a99b39-b4ad-a426-e053-dadaa90af4c2SaniHands GEL HAND SANITIZER
80497-001-042022-01-28C16284748780-1d6a99b39-b4ad-a426-e053-dadaa90af4c2SaniHands GEL HAND SANITIZER
80497-001-052022-01-28C16284748780-1d6a99b39-b4ad-a426-e053-dadaa90af4c2SaniHands GEL HAND SANITIZER
80497-001-912022-01-28C16284748780-1d6a99b39-b4ad-a426-e053-dadaa90af4c2SaniHands GEL HAND SANITIZER
80497-001-922022-01-28C16284748780-1d6a99b39-b4ad-a426-e053-dadaa90af4c2SaniHands GEL HAND SANITIZER
80497-001-932022-01-28C16284748780-1d6a99b39-b4ad-a426-e053-dadaa90af4c2SaniHands GEL HAND SANITIZER
80497-001-942022-01-28C16284748780-1d6a99b39-b4ad-a426-e053-dadaa90af4c2SaniHands GEL HAND SANITIZER
80497-001-952022-01-28C16284748780-1d6a99b39-b4ad-a426-e053-dadaa90af4c2SaniHands GEL HAND SANITIZER

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80497-001-01SaniHandsGel Hand Sanitizer3790 mL in 1 BOTTLE, PLASTICGEL37901
80497-001-02SaniHandsGel Hand Sanitizer950 mL in 1 BOTTLE, PLASTICGEL9501
80497-001-03SaniHandsGel Hand Sanitizer473 mL in 1 BOTTLE, PLASTICGEL4731
80497-001-04SaniHandsGel Hand Sanitizer236 mL in 1 BOTTLE, PLASTICGEL2361
80497-001-05SaniHandsGel Hand Sanitizer118 mL in 1 BOTTLE, PLASTICGEL1181
80497-001-91SaniHandsGel Hand Sanitizer1 in 1 CASEGEL11
80497-001-92SaniHandsGel Hand Sanitizer1 in 1 CASEGEL11
80497-001-93SaniHandsGel Hand Sanitizer1 in 1 CASEGEL11
80497-001-94SaniHandsGel Hand Sanitizer1 in 1 CASEGEL11
80497-001-95SaniHandsGel Hand Sanitizer1 in 1 CASEGEL11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80497-001SANIHANDS GEL HAND SANITIZER (ETHYL ALCOHOL) GEL [DYNASTY CHEMICAL CORP.]1Legacy NDC, 10 package rows20201126_b9cce04b-a875-416c-9c9e-0ebfa9d9d018.zip

Products#

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

DailyMed product names page 1 of 1 · 8 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
80497-00180497-001-05, 80497-001-95, 80497-001-04, 80497-001-94, 80497-001-03, 80497-001-93, 80497-001-02, 80497-001-92, 80497-001-01, 80497-001-91

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 6 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALCOHOL3K9958V90MACTIB
WATER059QF0KO0RIACT
POLYETHYLENE GLYCOL, UNSPECIFIED3WJQ0SDW1AIACT
GLYCERINPDC6A3C0OXIACT
HYDROGEN PEROXIDEBBX060AN9VIACT
DENATONIUM BENZOATE4YK5Z54AT2IACT

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
73160761-1b93-4c3c-af69-d5887fc1fdf2b9cce04b-a875-416c-9c9e-0ebfa9d9d0182020-11-17WarningsExact identifier
spl id: 73160761-1b93-4c3c-af69-d5887fc1fdf2
spl set id: b9cce04b-a875-416c-9c9e-0ebfa9d9d018

Reported adverse events (FAERS/openFDA)#

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