FDA.reportPublic FDA data

KLEENEX

Manufacturer
Kimberly-Clark Corporation | Hubot CDMO | Cyan Labs
Effective date
2026-05-08
Label type
HUMAN OTC DRUG LABEL
Version
8
Source
full-release
Hydrated at
2026-06-01 01:56:56

Label at a glance#

ProductKleenex Ultra Moisturizing Hand Sanitizer
Active ingredientAlcohol
Label structure10 sections

Indications and uses

To decrease bacteria on the skin that could potentially cause disease

Dosage and administration

Rub thoroughly into hands for at least 30 seconds. Allow to dry. Supervise children under 6 years of age when using this product.

Storage and handling

Do not store above 110 °F (40 °C).

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Ethyl Alcohol 70% v/v

Purpose

OTC - PURPOSE SECTION

Antiseptic

Uses

INDICATIONS & USAGE SECTION

To decrease bacteria on the skin that could potentially cause disease

Warnings

WARNINGS SECTION

For external use only

SPL UNCLASSIFIED SECTION

Flammable. Keep away from heat or flame.

OTC - DO NOT USE SECTION

Do not use on children less than 2 months of age or on open skin wounds

OTC - WHEN USING SECTION

When using this product avoid contact with eyes. If contact occurs, rinse thoroughly with water.

OTC - STOP USE SECTION

Stop use and ask a doctor if Irritation or rash occurs.

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

Rub thoroughly into hands for at least 30 seconds. Allow to dry. Supervise children under 6 years of age when using this product.

Other information

STORAGE AND HANDLING SECTION

Do not store above 110 °F (40 °C).

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Aloe Barbadensis Leaf Extract, Betaine, Camellia Sinensis Leaf Extract, Citric Acid, Cucumis Sativus Fruit Extract (Cucumber), Glycerin, Isopropanol, Meadowfoam Amidopropyl Betaine, Panthenol, PEG-10 Dimethicone, Water/Eau/Aqua

Questions?

OTC - QUESTIONS SECTION

1-888-346-4652

PRINCIPAL DISPLAY PANEL - 1.2 L Bottle Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

34643

Kleenex®
BRAND
ULTRA

Moisturizing Foam
Hand Sanitizer

Empty &
Discard Pump
PLASTIC
BOTTLE

how2recycle.info

ECOLOGO
PRODUCT CERTIFIED FOR
REDUCED ENVIRONMENTAL
IMPACT. VIEW SPECIFIC
ATTRIBUTES EVAUATED:
UL.COM/EL UL 2783

20-14-910-0-00

1.2L (40.5 fl oz)

PRINCIPAL DISPLAY PANEL - 1.2 L Bottle Label
PRINCIPAL DISPLAY PANEL - 1.2 L Bottle Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
616805ethanol 70 % Topical FoamPSN8
616805ethanol 0.7 ML/ML Topical FoamSCD8
616805ethanol 70 % Topical FoamSY8

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130036000346435GTIN-13: 0036000346435
EAN-13: 0036000346435
GTIN-12: 036000346435
UPC-A: 036000346435
GTIN storage (14 digits): 00036000346435		kleenex-01.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
d1c9d1af-bddd-448d-86f7-69052b7d5b47Product name120220627

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
55118-530-102022-12-14C16284748780-19d75b9d0-0d75-f424-e053-dadaa90a57ceKLEENEX ® ULTRA Moisturizing Foam Hand Sanitizer
55118-530-112022-12-14C16284748780-19d75b9d0-0d75-f424-e053-dadaa90a57ceKLEENEX ® ULTRA Moisturizing Foam Hand Sanitizer
55118-530-122022-12-14C16284748780-19d75b9d0-0d75-f424-e053-dadaa90a57ceKLEENEX ® ULTRA Moisturizing Foam Hand Sanitizer
55118-530-882022-12-14C16284748780-19d75b9d0-0d75-f424-e053-dadaa90a57ceKLEENEX ® ULTRA Moisturizing Foam Hand Sanitizer
55118-530-992022-12-14C16284748780-19d75b9d0-0d75-f424-e053-dadaa90a57ceKLEENEX ® ULTRA Moisturizing Foam Hand Sanitizer
55118-530-102020-01-31C16284748780-19d75b9d0-0d75-f424-e053-dadaa90a57ceKLEENEX ® ULTRA Moisturizing Foam Hand Sanitizer
55118-530-112020-01-31C16284748780-19d75b9d0-0d75-f424-e053-dadaa90a57ceKLEENEX ® ULTRA Moisturizing Foam Hand Sanitizer
55118-530-122020-01-31C16284748780-19d75b9d0-0d75-f424-e053-dadaa90a57ceKLEENEX ® ULTRA Moisturizing Foam Hand Sanitizer
55118-530-882020-01-31C16284748780-19d75b9d0-0d75-f424-e053-dadaa90a57ceKLEENEX ® ULTRA Moisturizing Foam Hand Sanitizer
55118-530-992020-01-31C16284748780-19d75b9d0-0d75-f424-e053-dadaa90a57ceKLEENEX ® ULTRA Moisturizing Foam Hand Sanitizer

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55118-530-10Kleenex Ultra Moisturizing Hand Sanitizer1000 mL in 1 BAGSOLUTION10008
55118-530-11Kleenex Ultra Moisturizing Hand Sanitizer44 mL in 1 BOTTLE, PLASTICSOLUTION448
55118-530-12Kleenex Ultra Moisturizing Hand Sanitizer1200 mL in 1 BAGSOLUTION12008
55118-530-63Kleenex Ultra Moisturizing Hand Sanitizer6 in 1 CARTONSOLUTION68
55118-530-65Kleenex Ultra Moisturizing Hand Sanitizer2 in 1 CARTONSOLUTION28
55118-530-88Kleenex Ultra Moisturizing Hand Sanitizer236 mL in 1 BOTTLE, PLASTICSOLUTION2368
55118-530-91Kleenex Ultra Moisturizing Hand Sanitizer1000 mL in 1 BOTTLESOLUTION10008
55118-530-92Kleenex Ultra Moisturizing Hand Sanitizer1200 mL in 1 BOTTLESOLUTION12008
55118-530-99Kleenex Ultra Moisturizing Hand Sanitizer472 mL in 1 BOTTLE, PLASTICSOLUTION4728

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
AlcoholACTIVE INGREDIENT3K9958V90M2
AlcoholACTIVE MOIETY3K9958V90M2
Aloe Vera LeafINACTIVE INGREDIENTZY81Z83H0X2
BetaineINACTIVE INGREDIENT3SCV180C9W2
Camellia Oleifera LeafINACTIVE INGREDIENT5077EL0C602
Citric Acid MonohydrateINACTIVE INGREDIENT2968PHW8QP2
CucumberINACTIVE INGREDIENTYY7C30VXJT2
GlycerinINACTIVE INGREDIENTPDC6A3C0OX2
Isopropyl AlcoholINACTIVE INGREDIENTND2M4163022
PanthenolINACTIVE INGREDIENTWV9CM0O67Z2
WaterINACTIVE INGREDIENT059QF0KO0R2

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
55118-53055118-530-91, 55118-530-63, 55118-530-92, 55118-530-65, 55118-530-11, 55118-530-88, 55118-530-99, 55118-530-10, 55118-530-12

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
Isopropyl AlcoholND2M416302IACT
Betaine3SCV180C9WIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
GREEN TEA LEAFW2ZU1RY8B0IACT
PanthenolWV9CM0O67ZIACT
GlycerinPDC6A3C0OXIACT
MEADOWFOAMAMIDOPROPYL BETAINEHNV0L650LGIACT
Aloe Vera LeafZY81Z83H0XIACT
CucumberYY7C30VXJTIACT

Source Document#

Source XML · Source PDF

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 30 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
Citric Acid MonohydrateCITRIC ACID MONOHYDRATE2968PHW8QPSOLUTION / TOPICAL17 mgExact identifier — unii+route+dosage form
10 equally ranked IID candidates
Citric Acid MonohydrateCITRIC ACID MONOHYDRATE2968PHW8QPSOLUTION / TOPICAL17 mgExact identifier — unii+route+dosage form
10 equally ranked IID candidates
Citric Acid MonohydrateCITRIC ACID MONOHYDRATE2968PHW8QPSOLUTION / TOPICAL17 mgExact identifier — unii+route+dosage form
10 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXSOLUTION / TOPICAL1971 mgExact identifier — unii+route+dosage form
10 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXSOLUTION / TOPICAL1971 mgExact identifier — unii+route+dosage form
10 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXSOLUTION / TOPICAL1971 mgExact identifier — unii+route+dosage form
10 equally ranked IID candidates
Citric Acid MonohydrateCITRIC ACID MONOHYDRATE2968PHW8QPSOLUTION / TOPICAL17 mgExact identifier — unii+route+dosage form
10 equally ranked IID candidates
Isopropyl AlcoholISOPROPYL ALCOHOLND2M416302SOLUTION / TOPICAL40 %w/vExact identifier — unii+route+dosage form
10 equally ranked IID candidates
Citric Acid MonohydrateCITRIC ACID MONOHYDRATE2968PHW8QPSOLUTION / TOPICAL17 mgExact identifier — unii+route+dosage form
10 equally ranked IID candidates
Isopropyl AlcoholISOPROPYL ALCOHOLND2M416302SOLUTION / TOPICAL40 %w/vExact identifier — unii+route+dosage form
10 equally ranked IID candidates
Isopropyl AlcoholISOPROPYL ALCOHOLND2M416302SOLUTION / TOPICAL40 %w/vExact identifier — unii+route+dosage form
10 equally ranked IID candidates
Isopropyl AlcoholISOPROPYL ALCOHOLND2M416302SOLUTION / TOPICAL40 %w/vExact identifier — unii+route+dosage form
10 equally ranked IID candidates
Isopropyl AlcoholISOPROPYL ALCOHOLND2M416302SOLUTION / TOPICAL40 %w/vExact identifier — unii+route+dosage form
10 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXSOLUTION / TOPICAL1971 mgExact identifier — unii+route+dosage form
10 equally ranked IID candidates
Isopropyl AlcoholISOPROPYL ALCOHOLND2M416302SOLUTION / TOPICAL40 %w/vExact identifier — unii+route+dosage form
10 equally ranked IID candidates
Citric Acid MonohydrateCITRIC ACID MONOHYDRATE2968PHW8QPSOLUTION / TOPICAL17 mgExact identifier — unii+route+dosage form
10 equally ranked IID candidates
Isopropyl AlcoholISOPROPYL ALCOHOLND2M416302SOLUTION / TOPICAL40 %w/vExact identifier — unii+route+dosage form
10 equally ranked IID candidates
Isopropyl AlcoholISOPROPYL ALCOHOLND2M416302SOLUTION / TOPICAL40 %w/vExact identifier — unii+route+dosage form
10 equally ranked IID candidates
Citric Acid MonohydrateCITRIC ACID MONOHYDRATE2968PHW8QPSOLUTION / TOPICAL17 mgExact identifier — unii+route+dosage form
10 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXSOLUTION / TOPICAL1971 mgExact identifier — unii+route+dosage form
10 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXSOLUTION / TOPICAL1971 mgExact identifier — unii+route+dosage form
10 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXSOLUTION / TOPICAL1971 mgExact identifier — unii+route+dosage form
10 equally ranked IID candidates
Isopropyl AlcoholISOPROPYL ALCOHOLND2M416302SOLUTION / TOPICAL40 %w/vExact identifier — unii+route+dosage form
10 equally ranked IID candidates
Isopropyl AlcoholISOPROPYL ALCOHOLND2M416302SOLUTION / TOPICAL40 %w/vExact identifier — unii+route+dosage form
10 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXSOLUTION / TOPICAL1971 mgExact identifier — unii+route+dosage form
10 equally ranked IID candidates
Citric Acid MonohydrateCITRIC ACID MONOHYDRATE2968PHW8QPSOLUTION / TOPICAL17 mgExact identifier — unii+route+dosage form
10 equally ranked IID candidates
Citric Acid MonohydrateCITRIC ACID MONOHYDRATE2968PHW8QPSOLUTION / TOPICAL17 mgExact identifier — unii+route+dosage form
10 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXSOLUTION / TOPICAL1971 mgExact identifier — unii+route+dosage form
10 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXSOLUTION / TOPICAL1971 mgExact identifier — unii+route+dosage form
10 equally ranked IID candidates
Citric Acid MonohydrateCITRIC ACID MONOHYDRATE2968PHW8QPSOLUTION / TOPICAL17 mgExact identifier — unii+route+dosage form
10 equally ranked IID candidates

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
Kleenex Ultra Moisturizing Hand SanitizerALCOHOLKimberly-Clark Corporation75e884bf-8e0d-41e7-adbb-4400ee3d1e072026-05-08WarningsExact identifier
ndc (package): 55118-530-91
ndc (package): 55118-530-10
ndc (package): 55118-530-65
ndc (package): 55118-530-88
ndc (package): 55118-530-11
ndc (package): 55118-530-99
ndc (package): 55118-530-12
ndc (package): 55118-530-63
ndc (package): 55118-530-92
ndc (product): 55118-530
ndc11 (package): 55118053065
ndc11 (package): 55118053010
ndc11 (package): 55118053011
ndc11 (package): 55118053099
ndc11 (package): 55118053091
ndc11 (package): 55118053063
ndc11 (package): 55118053088
ndc11 (package): 55118053012
ndc11 (package): 55118053092
spl id: 92ebe19a-e5cd-40cb-89ec-60d675a726d3
spl set id: 75e884bf-8e0d-41e7-adbb-4400ee3d1e07

Reported adverse events (FAERS/openFDA)#

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