FDA.reportPublic FDA data

Essentials by Catalina Hand Sanitizer Gel

Manufacturer
Maki Creations | Maki Creations, Inc.
Effective date
2020-06-04
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:16:11

Label at a glance#

ProductEssentials by Catalina Hand Sanitizer Gel
Active ingredientALCOHOL
Label structure12 sections

Indications and uses

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

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

Label contents#

Full prescribing information#

Active Ingredient[s]

OTC - ACTIVE INGREDIENT SECTION

Alcohol 80% v/v

Purpose

OTC - PURPOSE SECTION

Antiseptic

Uses[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

OTC - DO NOT USE SECTION

  • on children less than 2 months of age
  • on open skin wounds

OTC - WHEN USING SECTION

When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.

OTC - STOP USE SECTION

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

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Deionized Water, Glycerin, Propylene Glycol, Organic Aloe Barbadensis (Aloe Vera) Leaf Extract, Panthenol (Pro-Vitamin B5), Tocopheryl Acetate (Vitamin E Acetate), Carbomer, Aminomethyl Propanol

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Hand Sanitizer Gel Pail (5 Gallons)Hand Sanitizer Gel Pail (5 Gallons)Hand Sanitizer Gel Drum (55 Gallons)Hand Sanitizer Gel Drum (55 Gallons)Hand Sanitizer Gel Tank (Tote)Hand Sanitizer Gel Tank (Tote)Hand Sanitizer Gel 8ozHand Sanitizer Gel 8ozHand Sanitizer Gel GallonHand Sanitizer Gel Gallon

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
76902-027-012022-01-28C16284748780-1d6a99b39-f44a-a426-e053-dadaa90af4c2Essentials by Catalina Hand Sanitizer Gel
76902-027-022022-01-28C16284748780-1d6a99b39-f44a-a426-e053-dadaa90af4c2Essentials by Catalina Hand Sanitizer Gel
76902-027-032022-01-28C16284748780-1d6a99b39-f44a-a426-e053-dadaa90af4c2Essentials by Catalina Hand Sanitizer Gel
76902-027-042022-01-28C16284748780-1d6a99b39-f44a-a426-e053-dadaa90af4c2Essentials by Catalina Hand Sanitizer Gel
76902-027-052022-01-28C16284748780-1d6a99b39-f44a-a426-e053-dadaa90af4c2Essentials by Catalina Hand Sanitizer Gel

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76902-027-01Essentials by Catalina Hand Sanitizer Gel236 mL in 1 BOTTLELIQUID2361
76902-027-02Essentials by Catalina Hand Sanitizer Gel3785 mL in 1 JUGLIQUID37851
76902-027-03Essentials by Catalina Hand Sanitizer Gel18927 mL in 1 PAILLIQUID189271
76902-027-04Essentials by Catalina Hand Sanitizer Gel208197 mL in 1 DRUMLIQUID2081971
76902-027-05Essentials by Catalina Hand Sanitizer Gel1040987 mL in 1 TANKLIQUID10409871

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76902-027ESSENTIALS BY CATALINA HAND SANITIZER GEL (ALCOHOL) LIQUID [MAKI CREATIONS]1Legacy NDC, 5 package rows20200605_a748b3f1-2ed3-51b6-e053-2a95a90ae2fd.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
76902-02776902-027-01, 76902-027-02, 76902-027-03, 76902-027-04, 76902-027-05

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
WATER059QF0KO0RIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
GLYCERINPDC6A3C0OXIACT
PANTHENOLWV9CM0O67ZIACT
.ALPHA.-TOCOPHEROL ACETATE, D-A7E6112E4NIACT
ALCOHOL3K9958V90MACTIB
AMINOMETHYLPROPANOLLU49E6626QIACT
ALOE VERA LEAFZY81Z83H0XIACT
CARBOMER 9404Q93RCW27EIACT

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
a748b3f1-2ed4-51b6-e053-2a95a90ae2fda748b3f1-2ed3-51b6-e053-2a95a90ae2fd2020-06-04WarningsExact identifier
spl id: a748b3f1-2ed4-51b6-e053-2a95a90ae2fd
spl set id: a748b3f1-2ed3-51b6-e053-2a95a90ae2fd

Reported adverse events (FAERS/openFDA)#

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