FDA.reportPublic FDA data

SpectraGenix Hand Sanitizer

Manufacturer
Medical Chemical Corporation
Effective date
2022-01-17
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:47:07

Label at a glance#

ProductSpectraGenix Hand Sanitizer Antiseptic Hand Wash
Active ingredientALCOHOL
Label structure8 sections

Indications and uses

Intended for use as a hand sanitizer to reduce pathogenic bacteria. Recommended for repeated use. For external use on the skin only. Not for use on the eyes.

Dosage and administration

Spray about 5 g (1 tsp.) on to one hand and spread over both hands to the wrist. Rub into the skin until dry. Repeat.

Label contents#

Full prescribing information#

Purpose

OTC - PURPOSE SECTION

Germicide

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Ethyl Alcohol 70% v/v

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Purified water, Emollients (Laurel, Myristal and Cetyl Lactate,), Aloe Vera, Carbomer, Parabens, Diisopropylamine

Warnings

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Warnings: Flammable, keep away from fire or flame.  For external use only.  Do no use in the eyes.  Discontinue use if irritation or redness develops.  Keep out of reach of children.  In case of ingestion contact poison control center immediately.

Warnings

WARNINGS SECTION

Danger: Highly flammable liqid and vapor. Keep away from heat, sparks, open flames and hot surfaces. No smoking. Keep container tightly closed. Use only non-sparking tools. Take precautions against static discharge. In case of fire, use fire extinguishers approved for alcohol fires. In case of ingestion contact a poison control center. Discontinue use if irritation or redness develops. Keep out of reach of children.

Directions

DOSAGE & ADMINISTRATION SECTION

Spray about 5 g (1 tsp.) on to one hand and spread over both hands to the wrist. Rub into the skin until dry. Repeat.

Uses

INDICATIONS & USAGE SECTION

Intended for use as a hand sanitizer to reduce pathogenic bacteria. Recommended for repeated use. For external use on the skin only. Not for use on the eyes.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

spectragenixlabel.jpg

spectragenixlabelspectragenixlabel

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
12745-851-012024-01-30C16284748780-11030e365-4ec0-111a-e063-dadaa90a10e2SpectraGenix Hand Sanitizer
12745-851-022024-01-30C16284748780-11030e365-4ec0-111a-e063-dadaa90a10e2SpectraGenix Hand Sanitizer
12745-851-032024-01-30C16284748780-11030e365-4ec0-111a-e063-dadaa90a10e2SpectraGenix Hand Sanitizer

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
12745-851-01SpectraGenix Hand SanitizerAntiseptic Hand Wash473 mL in 1 BOTTLE, PLASTICLIQUID4732
12745-851-02SpectraGenix Hand SanitizerAntiseptic Hand Wash946 mL in 1 BOTTLE, PLASTICLIQUID9462
12745-851-03SpectraGenix Hand SanitizerAntiseptic Hand Wash3785 mL in 1 BOTTLE, PLASTICLIQUID37852

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
12745-851SPECTRAGENIX HAND SANITIZER ANTISEPTIC HAND WASH (ETHYL ALCOHOL) LIQUID [MEDICAL CHEMICAL CORPORATION]2Legacy NDC, 3 package rows20220118_b3294e36-5fd7-29ba-e053-2a95a90a2f56.zip

Products#

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

DailyMed product names page 1 of 1 · 9 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
12745-85112745-851-01, 12745-851-02, 12745-851-03

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

Name, UNII, Kind table
NameUNIIKind
SPIKE LAVENDER OIL7S2HYV1VJQIACT
CARBOMER HOMOPOLYMER TYPE C4Q93RCW27EIACT
CETYL LACTATEA7EVH2RK4OIACT
ALOE VERA LEAFZY81Z83H0XIACT
DIISOPROPYLAMINEBR9JLI40NOIACT
WATER059QF0KO0RIACT
ALCOHOL3K9958V90MACTIB

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
d5cc9f99-59ad-55db-e053-2995a90affb7b3294e36-5fd7-29ba-e053-2a95a90a2f562022-01-17WarningsExact identifier
spl id: d5cc9f99-59ad-55db-e053-2995a90affb7
spl set id: b3294e36-5fd7-29ba-e053-2a95a90a2f56

Reported adverse events (FAERS/openFDA)#

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