FDA.reportPublic FDA data

Commonwealth Pumpkin Spice Hand Sanitizer Gel

Manufacturer
Commonwealth Homes, Inc.
Effective date
2020-09-22
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:30:09

Label at a glance#

ProductCommonwealth Pumpkin Spice Hand Sanitizer
Active ingredientALCOHOL
Label structure10 sections

Indications and uses

hand sanitizer to decrease bacteria on the skin recommended for repeated use for use when soap and water are not available

Dosage and administration

wet hands thoroughly with product and allow to dry without wiping supervise children under 6 years of age when using this product to avoid swallowing

Storage and handling

store under 105° F

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Ethyl alcohol 70%

Purpose

OTC - PURPOSE SECTION

Antiseptic

Uses

INDICATIONS & USAGE SECTION

  • hand sanitizer to decrease bacteria on the skin
  • recommended for repeated use
  • for use when soap and water are not available

Warnings

WARNINGS SECTION

Flammable, keep away from fire / flame

For external use only

Do not use

  • on children less than 2 months of age
  • on open wounds

When using this product do not get into eyes. In case of contact, rinse eyes thoroughly with water

Stop use and ask doctor if

  • irritation and redness develop
  • condition persists for more than 72 hours

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

  • wet hands thoroughly with product and allow to dry without wiping
  • supervise children under 6 years of age when using this product to avoid swallowing

Other information

STORAGE AND HANDLING SECTION

  • store under 105° F

Inactive ingredients

INACTIVE INGREDIENT SECTION

Hydroxyethyl cellulose, Isopropyl myristate, Propylene glycol, Fragrance, Water

Questions?

OTC - QUESTIONS SECTION

1-937-470-5755

You can also report serious side effects to this phone number. Mon-Fri 9:00am - 5:00 pm

SPL UNCLASSIFIED SECTION

Tough on Germs

Not on Hands

Silky Smooth Formulation

Non Irritating

NATURAL INGREDIENT FORMULA

SULFATE - FREE

PARABEN - FREE

VEGAN

MADE IN USA

Manufactured by: Commonwealth Homes Inc, Centerville, Ohio, 45370

NOT LABELED FOR SALE IN CALIFORNIA

Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

untitleduntitled

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
73802-108-212022-01-28C16284748780-1d6a99b39-95cc-a426-e053-dadaa90af4c2Commonwealth Pumpkin Spice Hand Sanitizer Gel

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
73802-108-21Commonwealth Pumpkin Spice Hand Sanitizer59.14 mL in 1 BOTTLEGEL59.141

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
73802-108COMMONWEALTH PUMPKIN SPICE HAND SANITIZER (ETHYL ALCOHOL) GEL [COMMONWEALTH HOMES, INC.]1Legacy NDC, 1 package rows20200924_e8a6f3c7-84c6-42d1-83ee-8bdc17706f80.zip

Products#

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

DailyMed product names page 1 of 1 · 7 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
73802-10873802-108-21

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 5 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALCOHOL3K9958V90MACTIB
HYDROXYETHYL CELLULOSE, UNSPECIFIEDT4V6TWG28DIACT
ISOPROPYL MYRISTATE0RE8K4LNJSIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
WATER059QF0KO0RIACT

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
42b106a3-780b-4251-bf77-dbee3648f6bbe8a6f3c7-84c6-42d1-83ee-8bdc17706f802020-09-22WarningsExact identifier
spl id: 42b106a3-780b-4251-bf77-dbee3648f6bb
spl set id: e8a6f3c7-84c6-42d1-83ee-8bdc17706f80

Reported adverse events (FAERS/openFDA)#

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