FDA.reportPublic FDA data

Pure Gel Hand Sanitizer

Manufacturer
American Textile & Apparel Inc.
Effective date
2020-09-03
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:29:21

Label at a glance#

ProductPure Gel Hand Sanitizer
Active ingredientALCOHOL
Label structure9 sections

Indications and uses

• Hand sanitizer to help reduce bacteria that potentially can cause disease • For use when soap and water are not available.

Dosage and administration

• Place enough product on hands to cover all surfaces • Rub hands together until dry • Supervise children under 6 years of age when using this product to avoid swallowing

Storage and handling

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

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Ethyl Alcohol (70% 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 not available.

Warnings

WARNINGS SECTION

For external use only

Flammable. Keep away from fire or flames

Do not use

• In children less than 2 months of age • On open skin wounds.

When using this product

• Keep out of eyes, ears, and mouth
• In case of contact with eyes, rinse eyes thoroughly with water

Stop use and ask a doctor if

• Irritation or redness develops. These may be signs of a serious condition

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

• Place enough product on hands to cover all surfaces • Rub hands together until dry • Supervise children under 6 years of age when using this product to avoid swallowing

Other Information

STORAGE AND HANDLING SECTION

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

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Purified water, glycerin, aculyn excel, triethanolamine.

SPL UNCLASSIFIED SECTION

Kills 99.9% of Germs

PureGel kills germs while keeping your hands soft and supple.

Fragrance Free

PRODUCT OF HONDURAS

Cleanliness is extremely important. Protect your loved ones by utilizing PureGel to kill germs and keep your hands soft and fresh.

Our formula has proven to be highly effective to kill germs and keep our hands clean, all while promoting soft and non sticky skin.

MaskD Health LLC, 10408 West State Road 84, Davie, FL 33324.

1-844-308-0458     WWW.SHOPMASKDHEALTH.COM

Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PackagingPackaging

PackagingPackaging

PackagingPackaging

PackagingPackaging

PackagingPackaging

PackagingPackaging

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
581662ethanol 70 % Topical GelPSN2
581662ethanol 0.7 ML/ML Topical GelSCD2
581662ethanol 70 % Topical GelSY2
581662ethyl alcohol 70 % Topical GelSY2

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
79168-435-022022-01-28C16284748780-1d6a99b39-7b99-a426-e053-dadaa90af4c2Pure Gel™ Hand Sanitizer Gel
79168-435-042022-01-28C16284748780-1d6a99b39-7b99-a426-e053-dadaa90af4c2Pure Gel™ Hand Sanitizer Gel
79168-435-082022-01-28C16284748780-1d6a99b39-7b99-a426-e053-dadaa90af4c2Pure Gel™ Hand Sanitizer Gel
79168-435-162022-01-28C16284748780-1d6a99b39-7b99-a426-e053-dadaa90af4c2Pure Gel™ Hand Sanitizer Gel
79168-435-412022-01-28C16284748780-1d6a99b39-7b99-a426-e053-dadaa90af4c2Pure Gel™ Hand Sanitizer Gel
79168-435-452022-01-28C16284748780-1d6a99b39-7b99-a426-e053-dadaa90af4c2Pure Gel™ Hand Sanitizer Gel

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
79168-435-02Pure Gel Hand Sanitizer59.15 mL in 1 BOTTLEGEL59.152
79168-435-04Pure Gel Hand Sanitizer118.3 mL in 1 BOTTLEGEL118.32
79168-435-08Pure Gel Hand Sanitizer236.5 mL in 1 BOTTLEGEL236.52
79168-435-16Pure Gel Hand Sanitizer473 mL in 1 BOTTLEGEL4732
79168-435-41Pure Gel Hand Sanitizer3785 mL in 1 BOTTLEGEL37852
79168-435-45Pure Gel Hand Sanitizer18925 mL in 1 PAILGEL189252

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
79168-435PURE GEL HAND SANITIZER (ETHYL ALCOHOL) GEL [AMERICAN TEXTILE & APPAREL INC.]2Legacy NDC, 6 package rows20200915_d3f80d9b-dc52-4043-a537-ab9b9665ac0f.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
79168-43579168-435-02, 79168-435-04, 79168-435-08, 79168-435-16, 79168-435-41, 79168-435-45

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
WATER059QF0KO0RIACT
GLYCERINPDC6A3C0OXIACT
ACULYN EXCEL (POLYMER DISPERSION)RD9Y6KOY5SIACT
TROLAMINE9O3K93S3TKIACT

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
b1964630-68b1-4a41-ab6a-ed7f55d1f8b2d3f80d9b-dc52-4043-a537-ab9b9665ac0f2020-09-03WarningsExact identifier
spl id: b1964630-68b1-4a41-ab6a-ed7f55d1f8b2
spl set id: d3f80d9b-dc52-4043-a537-ab9b9665ac0f

Reported adverse events (FAERS/openFDA)#

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