FDA.reportPublic FDA data

PURELL Cottony Soft Hand Sanitizing Wipe

Manufacturer
GOJO Industries, Inc.
Effective date
2020-10-08
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:31:15

Label at a glance#

ProductPURELL Cottony Soft Hand Sanitizing Wipe
Active ingredientALCOHOL
Label structure12 sections

Dosage and administration

Tear open, unfold and apply to hands Children under 6 years of age should be supervised when using PURELL

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Ethyl alcohol 62%

Purpose

OTC - PURPOSE SECTION

Antimicrobial

Use

INDICATIONS & USAGE SECTION

  • Hand sanitizer to help reduce bacteria on the skin

Warnings

WARNINGS SECTION

Flammable. Keep away from fire or flame.

For external use only

When using this product

OTC - WHEN USING SECTION

do not use in or near the eyes. In case of contact, rinse eyes thoroughly with water.

Stop use and ask a doctor

OTC - STOP USE SECTION

if irritation or rash appears and lasts

Keep Out of Reach of Children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • Tear open, unfold and apply to hands
  • Children under 6 years of age should be supervised when using PURELL

Other information

SPL UNCLASSIFIED SECTION

  • Store below 110°F (43°C)
  • May discolor certain fabrics or surfaces

Questions?

OTC - QUESTIONS SECTION

  • Call 1-800-321-9647 Monday through Friday 8:30 AM to 5:00 PM
  • www.PURELL.com

Inactive ingredients

INACTIVE INGREDIENT SECTION

Water (Aqua), Isopropyl Alcohol, Glycerin, Acetamidopropyl Trimonium Chloride, Aloe Barbadensis Leaf Juice, C12-15 Alkyl Benzoate, Cocamidopropyl PG-Dimonium Chloride Phosphate, Isopropyl Myristate, Propylene Glycol, Retinyl Palmitate, Tocopheryl Acetate, Zea Mays (Corn) Oil, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Aminomethyl Propanol, Fragrance (Parfum), Methylparaben

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Cottony Soft Label 1 Ct.Cottony Soft Label 1 Ct.

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1041780ethanol 62 % Medicated PadPSN2
1041780ethanol 0.62 ML/ML Medicated PadSCD2
1041780ethanol 62 % Hand Sanitizer WipesSY2
1041780ethanol 62 % Medicated PadSY2
1041780ethanol 62 % Topical ClothSY2
1041780ethanol 62 % Topical SwabSY2

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
21749-364-012023-01-30C16284748780-1f386c64a-2300-0266-e053-dadaa90a7c1aPURELL Cottony Soft Hand Sanitizing Wipe

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
21749-364-01PURELL Cottony Soft Hand Sanitizing Wipe4 mL in 1 POUCHCLOTH42
21749-364-01PURELL Cottony Soft Hand Sanitizing Wipe1 in 1 PACKAGECLOTH12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
21749-364PURELL COTTONY SOFT HAND SANITIZING WIPE (ALCOHOL) CLOTH [GOJO INDUSTRIES, INC.]2Current NDC, Legacy NDC, 2 package rows20201009_ae57122d-130f-fde1-e053-2a95a90a96b3.zip

Products#

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

DailyMed product names page 1 of 1 · 16 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
21749-36421749-364-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 15 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
ISOPROPYL ALCOHOLND2M416302IACT
GLYCERINPDC6A3C0OXIACT
BEHENTRIMONIUM CHLORIDEX7GNG3S47TIACT
ALOE VERA LEAFZY81Z83H0XIACT
ALKYL (C12-15) BENZOATEA9EJ3J61HQIACT
COCAMIDOPROPYL PG-DIMONIUM CHLORIDE PHOSPHATEH2KVQ74JM4IACT
ISOPROPYL MYRISTATE0RE8K4LNJSIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
VITAMIN A PALMITATE1D1K0N0VVCIACT
.ALPHA.-TOCOPHEROL ACETATE, D-A7E6112E4NIACT
AMINOMETHYLPROPANOLLU49E6626QIACT
CORN OIL8470G57WFMIACT
METHYLPARABENA2I8C7HI9TIACT
ALCOHOL3K9958V90MACTIB

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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
PURELL Cottony Soft Hand Sanitizing WipeALCOHOLGOJO Industries, Inc.fc19689f-4826-4adf-8292-ea002cc4ad052024-12-12WarningsExact identifier
ndc (product): 21749-364
b12b798a-5b56-ccd4-e053-2a95a90a0a4dae57122d-130f-fde1-e053-2a95a90a96b32020-10-08WarningsExact identifier
spl id: b12b798a-5b56-ccd4-e053-2a95a90a0a4d
spl set id: ae57122d-130f-fde1-e053-2a95a90a96b3

Reported adverse events (FAERS/openFDA)#

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