FDA.reportPublic FDA data

Chemisphere Hand Sanitizer

Manufacturer
Chemisphere Corp
Effective date
2016-05-09
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 22:46:09

Label at a glance#

ProductChemisphere Hand Sanitizer
Active ingredientALCOHOL
Label structure8 sections

Dosage and administration

Wet hands with enough product to cover hands. Rub hands together and allow to dry. Children under 6 require adult supervision.

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Ethyl Alcohol 63%

OTC - PURPOSE SECTION

Antimicrobial

Directions

DOSAGE & ADMINISTRATION SECTION

Wet hands with enough product to cover hands. Rub hands together and allow to dry.

Children under 6 require adult supervision.

Warnings

WARNINGS SECTION

For external use only.

Flammable. Keep away from heat and flame.

When using this product keep out of eyes. In case of contact with eyes, flush thoroughly with water. Avoid contact with broken skin. Do not inhale or ingest.

Stop use and ask a doctor is irritation or rash develops.

INACTIVE INGREDIENT SECTION

Water, Glycerin, Tocopheryl Acetate, T-Butyl Alcohol, Carbomer, Fragrance

INDICATIONS & USAGE SECTION

Hand sanitizer to decrease bacterial on the skin.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If swallowed, get medical help of contact a Poison Control Center right away.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Hand saniziterHand saniziter

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1094724ethanol 63 % Topical GelPSN2
1094724ethanol 0.63 ML/ML Topical GelSCD2
1094724ethanol 63 % Topical GelSY2

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
61034-001-022020-01-31C16284748780-19d75b9d1-1cc5-f424-e053-dadaa90a57ce2fd2abfe-eb46-1cb0-e054-00144ff88e88

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61034-001-02Chemisphere Hand Sanitizer59 mL in 1 BOTTLE, PLASTICGEL592

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61034-001CHEMISPHERE HAND SANITIZER (HAND SANITIZER) GEL [CHEMISPHERE CORP]2Legacy NDC, 1 package rows20160601_2fd2abfe-eb46-1cb0-e054-00144ff88e88.zip

Products#

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

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
61034-00161034-001-02

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
ALCOHOL3K9958V90MACTIB
DIISOPROPYLAMINEBR9JLI40NOIACT
CARBOMER INTERPOLYMER TYPE A (55000 CPS)59TL3WG5COIACT
TERT-BUTYL ALCOHOLMD83SFE959IACT
DENATONIUM BENZOATE4YK5Z54AT2IACT
GLYCERINPDC6A3C0OXIACT
WATER059QF0KO0RIACT
ALPHA-TOCOPHEROL ACETATE9E8X80D2L0IACT

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
326f2582-93b3-2d1f-e054-00144ff8d46c2fd2abfe-eb46-1cb0-e054-00144ff88e882016-05-09WarningsExact identifier
spl id: 326f2582-93b3-2d1f-e054-00144ff8d46c
spl set id: 2fd2abfe-eb46-1cb0-e054-00144ff88e88

Reported adverse events (FAERS/openFDA)#

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