FDA.reportPublic FDA data

Kandesn

Manufacturer
Sunrider Manufacturing L.P.
Effective date
2020-04-22
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:08:11

Label at a glance#

ProductKandesn
Active ingredientAlcohol
Label structure10 sections

Indications and uses

For handwashing to decrease bacteria on the skin Recommended for repeated use throughout the day

Dosage and administration

Place enough product in your palm to cover hands, rub hands together briskly until dry Children under 6 years of age should be supervised when using this product

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Ethyl Alcohol 70%

Purpose

OTC - PURPOSE SECTION

Antiseptic

Uses

INDICATIONS & USAGE SECTION

  • For handwashing to decrease bacteria on the skin
  • Recommended for repeated use throughout the day

Warnings

WARNINGS SECTION

For external use only

Flammable. Keep away from fire or flame.

OTC - WHEN USING SECTION

When using this product do not use in or near the eyes. Incase of contact, rinse eyes thoroughly with water.

OTC - STOP USE SECTION

Stop use and ask a doctor if irritation or rash appears and lasts

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 in your palm to cover hands, rub hands together briskly until dry
  • Children under 6 years of age should be supervised when using this product

Other information

OTHER SAFETY INFORMATION

Store below 110⁰F (43⁰C)

  • May discolor certain fabrics or surfaces

Inactive ingredients

INACTIVE INGREDIENT SECTION

Water (Deionized), Salix Alba (Willow) Bark Extract, Ammonium Acryloyldimethyltaurate/VP Copolymer, Camellia Sinensis Leaf Extract, Menthol, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Laurus Nobilis Leaf Extract, Rosmarinus Officinalis (Rosemary) Leaf Extract, PEG-40 Hydrogenated Castor Oil, Oleth-20, Fragrance

Questions or comments?

OTC - QUESTIONS SECTION

Call 1-310-781-8096

Principal Display Panel – 60 mL Bottle Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

KANDESN®

HAND
CLEANSING
GEL

70% Alcohol

SUNRIDER®

NET WT.

2 fl. oz. (60 mL)

Principal Display Panel – 60 mL Bottle Label
Principal Display Panel – 60 mL Bottle Label

DailyMed RxNorm Mappings#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
7792dadb-52b6-46b6-8fdf-80b1171065b5Product name120180810

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
62191-085-082022-01-28C16284748780-1d6a99b39-bf1a-a426-e053-dadaa90af4c20ddc7596-ef92-4ec8-82f3-57651dbdfd7c

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
62191-085-08Kandesn60 mL in 1 TUBEGEL601

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62191-085KANDESN (ALCOHOL) GEL [SUNRIDER MANUFACTURING L.P.]1Legacy NDC, 1 package rows20200428_0ddc7596-ef92-4ec8-82f3-57651dbdfd7c.zip

Products#

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

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
62191-08562191-085-08

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
Water059QF0KO0RIACT
Salix Alba Bark205MXS71H7IACT
Ammonium Acryloyldimethyltaurate/VP CopolymerW59H9296ZGIACT
Green Tea leafW2ZU1RY8B0IACT
Menthol, Unspecified FormL7T10EIP3AIACT
Tea Tree OilVIF565UC2GIACT
Bay LeafWS0Y3M85RFIACT
RosemaryIJ67X351P9IACT
Polyoxyl 40 Hydrogenated Castor Oil7YC686GQ8FIACT
Oleth-20YTH167I2AGIACT

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
05ba4794-5ff6-4b31-b0d2-8a996e877be40ddc7596-ef92-4ec8-82f3-57651dbdfd7c2020-04-22WarningsExact identifier
spl id: 05ba4794-5ff6-4b31-b0d2-8a996e877be4
spl set id: 0ddc7596-ef92-4ec8-82f3-57651dbdfd7c

Reported adverse events (FAERS/openFDA)#

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