FDA.reportPublic FDA data

JMJ Catalina

Manufacturer
JMJ CATALINA USA LLC
Effective date
2020-06-16
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:18:29

Label at a glance#

ProductJMJ Catalina
Active ingredientALCOHOL
Label structure9 sections

Dosage and administration

• Place enough product on hands to cover all surfaces.  Rub hands together until dry. • Supervise children under 6 years of age when using this product to avoid swallowing.

Storage and handling

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

Label contents#

Full prescribing information#

Active Ingredient(s)

OTC - ACTIVE INGREDIENT SECTION

Ethyl alcohol 70% v/v

Purpose

OTC - PURPOSE SECTION

Antiseptic

Use(s)

INDICATIONS & USAGE SECTION

Hand sanitizer to help reduce bacteria that potentially can cause disease.

For use when soap and water are not available.

Warnings

WARNINGS SECTION

For external use only. Flammable. Keep away from heat or flame

Do not use

• In 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 for 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 on hands to cover all surfaces. Rub hands together until dry.

• Supervise children under 6 years of age when using this product to avoid swallowing.

Other information

STORAGE AND HANDLING SECTION

• Store between 15-30C (59-86F)

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

INACTIVE INGREDIENT SECTION

Inactive Ingredients Water, Carbomer, Aminomethyl propanol, Triethanolamine, Aloe, Fragrance, Glycerin, Propylene glycol, Tocopheryl acetate

SPL UNCLASSIFIED SECTION

Topical Solution

KILLS 99.99% OF GERMS* INCLUDING COVID-19

MADE IN U. S. A.

Peach

Manufactured by: 

JMJ Catalina U. S. A. LLC

Tucson, AZ 85714

Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage description

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
78938-333-252022-01-28C16284748780-1d6a99b39-a9b6-a426-e053-dadaa90af4c2JMJ Catalina HAND SANITIZER
78938-333-272022-01-28C16284748780-1d6a99b39-a9b6-a426-e053-dadaa90af4c2JMJ Catalina HAND SANITIZER
78938-333-292022-01-28C16284748780-1d6a99b39-a9b6-a426-e053-dadaa90af4c2JMJ Catalina HAND SANITIZER

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
78938-333-25JMJ Catalina500 mL in 1 BOTTLEGEL5001
78938-333-27JMJ Catalina100 mL in 1 BOTTLEGEL1001
78938-333-29JMJ Catalina3785 mL in 1 BOTTLEGEL37851

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
78938-333JMJ CATALINA (ETHYL ALCOHOL) GEL [JMJ CATALINA USA LLC]1Legacy NDC, 3 package rows20200622_844db589-9212-44cd-a289-2e2927bb2ab1.zip

Products#

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

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
78938-33378938-333-25, 78938-333-27, 78938-333-29

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALCOHOL3K9958V90MACTIB
WATER059QF0KO0RIACT
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE0A5MM307FCIACT
AMINOMETHYLPROPANOLLU49E6626QIACT
TROLAMINE9O3K93S3TKIACT
ALOEV5VD430YW9IACT
GLYCERINPDC6A3C0OXIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
.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
25c4c6df-8714-402c-8d36-cd66e4b2577a844db589-9212-44cd-a289-2e2927bb2ab12020-06-16WarningsExact identifier
spl id: 25c4c6df-8714-402c-8d36-cd66e4b2577a
spl set id: 844db589-9212-44cd-a289-2e2927bb2ab1

Reported adverse events (FAERS/openFDA)#

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