FDA.reportPublic FDA data

THOMAS AND FRIENDS HAND SANITIZER

Manufacturer
Ashtel Studios, Inc
Effective date
2019-12-31
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:02:38

Label at a glance#

ProductTHOMAS AND FRIENDS HAND SANITIZER
Active ingredientCHLOROXYLENOL
Label structure10 sections

Dosage and administration

• Place enough product in palm to cover hands and rub hands together briskly until dry. • Children under 6, use only under adult supervision. • Not recommended for infants.

Storage and handling

• Do not store above 100° F (38° C). • May discolor some fabrics. • Harmful to wood finishes and plastics.

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

CHLOROXYLENOL 0.05%

Purpose

OTC - PURPOSE SECTION

Antiseptic

Use

INDICATIONS & USAGE SECTION

To help reduce bacteria and germs on the skin.

Warning

WARNINGS SECTION

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

• Stop use and ask a doctor if irritation or redness develops and persists.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

• Keep out of reach of children. In case of accidental digestion, seek professional assistance or contact a Poison Control Center immediately.

Directions

DOSAGE & ADMINISTRATION SECTION

• Place enough product in palm to cover hands and rub hands together briskly until dry. • Children under 6, use only under adult supervision. • Not recommended for infants.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Aqua, Propylene Glycol, Phenoxyethanol, Coceth-7, Ppg-1-peg-9 Lauryl Glycol Ether, Peg-40 Hydrogenated Castor Oil, Acrylates/c10-30 Alkyl Acrylate Crosspolymer, Parfum, Sodium Hydroxide.

Other Information

STORAGE AND HANDLING SECTION

• Do not store above 100° F (38° C). • May discolor some fabrics. • Harmful to wood finishes and plastics.

SPL UNCLASSIFIED SECTION

KILLS 99.9% OF GERMS

HAND SANITIZER
DESINFECTANTE DE MANOS
DESINFECTANT POUR MAINS

DESIGNED IN U.S.A.
MANUFACTURED IN CHINA

www.smartcareus.com
QUESTIONS OR COMMENTS?
1-877-274-8358 TOLL FREE IN US
1-909-434-0911 INTERNATIONAL

 Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage description

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
198572chloroxylenol 0.05 % Topical SolutionPSN2
198572chloroxylenol 0.5 MG/ML Topical SolutionSCD2
198572chloroxylenol 0.05 % Topical SolutionSY2

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70108-009-012024-01-30C16284748780-11030e365-6216-111a-e063-dadaa90a10e2THOMAS AND FRIENDS HAND SANITIZER

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70108-009-01THOMAS AND FRIENDS HAND SANITIZER59 mL in 1 BOTTLELIQUID592

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70108-009THOMAS AND FRIENDS HAND SANITIZER (CHLOROXYLENOL) LIQUID [ASHTEL STUDIOS, INC]2Legacy NDC, 1 package rows20200101_3fa667db-c3ac-4c1b-994e-81300bae1eb6.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
70108-00970108-009-01

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
CHLOROXYLENOL0F32U78V2QACTIB
WATER059QF0KO0RIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
PHENOXYETHANOLHIE492ZZ3TIACT
COCETH-758Y261JLH5IACT
PPG-1-PEG-9 LAURYL GLYCOL ETHER5R8J43K25LIACT
POLYOXYL 40 HYDROGENATED CASTOR OIL7YC686GQ8FIACT
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED)59TL3WG5COIACT
SODIUM HYDROXIDE55X04QC32IIACT

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
cf967ba4-96a3-438d-b4b2-10d53d2575f63fa667db-c3ac-4c1b-994e-81300bae1eb62019-12-31WarningsExact identifier
spl id: cf967ba4-96a3-438d-b4b2-10d53d2575f6
spl set id: 3fa667db-c3ac-4c1b-994e-81300bae1eb6

Reported adverse events (FAERS/openFDA)#

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