Purple Mountain Clean Hand Sanitizer

Manufacturer
Edison Nation, Inc.
Effective date
2020-08-19
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:26:30

Label at a glance#

ProductPurple Mountain Clean Hand Sanitizer
Active ingredientISOPROPYL ALCOHOL, ALCOHOL
Label structure9 sections

Indications and uses

Hand sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are unavailable.

Dosage and administration

Place enough product on hands to cover all surfaces. Rub hands together until dry. For children under 6, use with adult supervision. Not recommended for infants.

Storage and handling

Store between 15-30C (59-86F). Avoid freezing and excessive heat above 40C (104F).

Label contents#

Full prescribing information#

Active Ingredients: 

OTC - ACTIVE INGREDIENT SECTION

Isopropyl Alcohol 60% v/v

Ethyl Alcohol 10% v/v

Purpose:

OTC - PURPOSE SECTION

antiseptic

Uses: 

INDICATIONS & USAGE SECTION

Hand sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are unavailable.

Warnings:

WARNINGS SECTION

For external use only. Flammable. Keep away from heat and flame, avoid contact with eyes. In case of contact with eyes, flush thoroughly with water. Avoid contact with broken skin. Stop use and askdoctor if irritation or redness develops, or if 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

Place enough product on hands to cover all surfaces. Rub hands together until dry. For children under 6, use with adult supervision. Not recommended for infants.

Other info:

STORAGE AND HANDLING SECTION

Store between 15-30C (59-86F).

Avoid freezing and excessive heat above 40C (104F).

Inactive Ingredients:

INACTIVE INGREDIENT SECTION

Carbomer, ethanolamine, polyethylene glycol, water USP, Fragrance.

SPL UNCLASSIFIED SECTION

Refreshing Gel

Made in the USA

Kills more than 99.9% of germs

70%alcohol

60% Isopropyl /10% Ethyl

100% SATISFACTION 

GUARANTEED

Distributed by:

GLOBAL CLEAN SOLUTIONS

WARNING

Extremely flammable

Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Purple2Purple2

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
424daadb-95de-8ece-97f5-235e3f7f0001Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
80120-101-002022-01-28C16284748780-1d6a99b39-4643-a426-e053-dadaa90af4c2PURPLE MOUNTAIN CLEAN HAND SANITIZER
80120-101-162022-01-28C16284748780-1d6a99b39-4643-a426-e053-dadaa90af4c2PURPLE MOUNTAIN CLEAN HAND SANITIZER

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80120-101-00Purple Mountain Clean Hand Sanitizer3.785 L in 1 JUGGEL3.7851
80120-101-16Purple Mountain Clean Hand Sanitizer0.473 L in 1 BOTTLE, PLASTICGEL0.4731

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80120-101PURPLE MOUNTAIN CLEAN HAND SANITIZER (ISOPROPYL ALCOHOL, ETHYL ALCOHOL) GEL [EDISON NATION, INC.]1Legacy NDC, 2 package rows20200902_59e2501d-e087-4904-957a-e41130e1370f.zip

Products#

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

DailyMed product names page 1 of 1 · 8 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
80120-10180120-101-00, 80120-101-16

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 6 matching rows.

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
711fe64d-6237-4c3c-aa83-ee08ebd566af59e2501d-e087-4904-957a-e41130e1370f2020-08-19WarningsExact identifier
spl id: 711fe64d-6237-4c3c-aa83-ee08ebd566af
spl set id: 59e2501d-e087-4904-957a-e41130e1370f

Reported adverse events (FAERS/openFDA)#

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