FDA.reportPublic FDA data

Kate Naturals Advanced Hand Sanitizer 70%

Manufacturer
THE DOJO LLC
Effective date
2020-05-09
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:10:32

Label at a glance#

ProductKate Naturals Advanced Hand Sanitizer Original
Active ingredientALCOHOL
Label structure15 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.

Storage and handling

Store under 105F

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

This hand sanitizer is manufactured using the following ingredients:

Ethyl Alcohol (70%, v/v) in an aqueous solution denatured according to Alcohol and Tobacco Tax and Trade Bureau regulations in 27 CFR part 20.

Aloe Barbadensis Leaf

Carbomer

Glycerol

Triethanolamine

Active Ingredients(s)

OTC - ACTIVE INGREDIENT SECTION

Ethyl Alcohol 70% v/v. Purpose: Antiseptic

Purpose

OTC - PURPOSE SECTION

Antiseptic, Hand Sanitizer

Use

INDICATIONS & USAGE SECTION

Hand sanitizer to help reduce bacteria on the skin

Warnings

WARNINGS SECTION

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

OTC - WHEN USING SECTION

When using this product, keep out of eyes, ears, and mouth.

In case of contact with eyes, rinse eyes throughly 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 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.

Other information

STORAGE AND HANDLING SECTION

Store under 105F

Inactive ingredients

INACTIVE INGREDIENT SECTION

Water (Aqua), Glycerol, Aloe Barbadensis Leaf Juice, Carbomer, Triethanolamine

Package Level - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

500ml NDC: 75498-170-16

Hand Sanitizer 500ml 70Hand Sanitizer 500ml 70

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

237ml NDC: 75498-170-08

Hand Sanitizer 237ml 170-8Hand Sanitizer 237ml 170-8

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

237ml NDC: 75498-175-08

Hand Sanitizer 8oz 175-8Hand Sanitizer 8oz 175-8

Package Label - Principala Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

500ml NDC: 75498-175-16

Hand Sanitizer 16oz 175-16Hand Sanitizer 16oz 175-16

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
581662ethanol 70 % Topical GelPSN1
1305100ethanol 75 % Topical GelPSN1
581662ethanol 0.7 ML/ML Topical GelSCD1
1305100ethanol 0.75 ML/ML Topical GelSCD1
581662ethanol 70 % Topical GelSY1
1305100ethanol 75 % Topical GelSY1
581662ethyl alcohol 70 % Topical GelSY1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
75498-170-082022-01-28C16284748780-1d6a99b39-711c-a426-e053-dadaa90af4c2a532ea21-3c39-3f2b-e053-2a95a90a67f2
75498-170-162022-01-28C16284748780-1d6a99b39-711c-a426-e053-dadaa90af4c2a532ea21-3c39-3f2b-e053-2a95a90a67f2
75498-175-082022-01-28C16284748780-1d6a99b39-711c-a426-e053-dadaa90af4c2a532ea21-3c39-3f2b-e053-2a95a90a67f2
75498-175-162022-01-28C16284748780-1d6a99b39-711c-a426-e053-dadaa90af4c2a532ea21-3c39-3f2b-e053-2a95a90a67f2

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
75498-170-08Kate Naturals Advanced Hand Sanitizer 70%237 mL in 1 BOTTLEGEL2371
75498-170-16Kate Naturals Advanced Hand Sanitizer 70%500 mL in 1 BOTTLEGEL5001
75498-175-08Kate Naturals Advanced Hand Sanitizer Original237 mL in 1 BOTTLEGEL2371
75498-175-16Kate Naturals Advanced Hand Sanitizer Original500 mL in 1 BOTTLEGEL5001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
75498-170KATE NATURALS ADVANCED HAND SANITIZER ORIGINAL (ALCOHOL) GEL KATE NATURALS ADVANCED HAND SANITIZER 70% (ALCOHOL) GEL [THE DOJO LLC]1Legacy NDC, 2 package rows20200510_a532ea21-3c39-3f2b-e053-2a95a90a67f2.zip
75498-175KATE NATURALS ADVANCED HAND SANITIZER ORIGINAL (ALCOHOL) GEL KATE NATURALS ADVANCED HAND SANITIZER 70% (ALCOHOL) GEL [THE DOJO LLC]1Legacy NDC, 2 package rows20200510_a532ea21-3c39-3f2b-e053-2a95a90a67f2.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
75498-17575498-175-08, 75498-175-16
75498-17075498-170-16, 75498-170-08

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALCOHOL3K9958V90MACTIB
ACRYLIC ACID/SODIUM ACRYLATE COPOLYMER (1:1; 600 MPA.S AT 0.2%)M4PPW69Y4HIACT
GLYCERINPDC6A3C0OXIACT
TROLAMINE9O3K93S3TKIACT
WATER059QF0KO0RIACT
TROLAMINE9O3K93S3TKIACT
ALCOHOL3K9958V90MACTIB
GLYCERINPDC6A3C0OXIACT
WATER059QF0KO0RIACT
ALOE VERA LEAFZY81Z83H0XIACT
CARBOMER 9404Q93RCW27EIACT

Source Document#

Source XML · Source PDF

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
a532ea21-3c3a-3f2b-e053-2a95a90a67f2a532ea21-3c39-3f2b-e053-2a95a90a67f22020-05-09WarningsExact identifier
spl id: a532ea21-3c3a-3f2b-e053-2a95a90a67f2
spl set id: a532ea21-3c39-3f2b-e053-2a95a90a67f2

Reported adverse events (FAERS/openFDA)#

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