FDA.reportPublic FDA data

Arch Packaging INSTANT Gel HAND SANITIZER

Manufacturer
Arch Packaging Technologies Llc
Effective date
2020-09-04
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:29:05

Label at a glance#

ProductArch Packaging INSTANT Gel HAND SANITIZER
Active ingredientALCOHOL
Label structure9 sections

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

Label contents#

Full prescribing information#

Active ingredient[s]

OTC - ACTIVE INGREDIENT SECTION

70% Ethanol by Volume

Purpose

OTC - PURPOSE SECTION

Antiseptic

Use[s]

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 heat or flame.
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 rash occurs. These may be signs of a serious condition.

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.
• Supervise children under 6 years of age when using this product to avoid swallowing.

Other information

STORAGE AND HANDLING SECTION

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

Inactive ingredients

INACTIVE INGREDIENT SECTION

Carbopol (Thickener), Glycerin, Fragrance, Vitamin E, Tertiary Butyl Alcohol, Denatonium Benzoate, Diisopropylamine

SPL UNCLASSIFIED SECTION

With Moisturizers and Vitamin E

Gentle Enough for Everyday Use

70% Ethyl Alcohol

DANGER: Highly Flammable liquid and vapor. Causes serious eye irritation. Keep container tightly closed. Keep out of reach of children. Keep away from heat/sparks/open flames/hot surfaces. No smoking. Use only non-sparking tools. Take precautionary measures against static discharge. May discolor certain fabrics or surfaces.
California SCAQMD Rule 443.1 VOC’S:
VOC: 70.50%

IN CASE OF FIRE: Use dry sand, dry chemical or alcohol-resistant foam to extinguish. Dispose of contents/container in accordance with local/regional/national/international regulations.
See SDS for Additional Information

Manufactured in St. Louis, MO

ARCH PACKAGING TECHNOLOGIES

10077 US HWY 61
Sainte Genevieve, MO 63670
www.archpackagingtechnologies.com

MADE IN USA

Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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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
79847-001-002022-01-28C16284748780-1d6a99b39-e1f0-a426-e053-dadaa90af4c2INSTANT GEL HAND SANITIZER
79847-001-012022-01-28C16284748780-1d6a99b39-e1f0-a426-e053-dadaa90af4c2INSTANT GEL HAND SANITIZER

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
79847-001-00Arch Packaging INSTANT Gel HAND SANITIZER3785 mL in 1 BOTTLEGEL37851
79847-001-01Arch Packaging INSTANT Gel HAND SANITIZER946 mL in 1 BOTTLEGEL9461

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
79847-001ARCH PACKAGING INSTANT GEL HAND SANITIZER (ETHYL ALCOHOL) GEL [ARCH PACKAGING TECHNOLOGIES LLC]1Legacy NDC, 2 package rows20200911_daa3cc5c-5d0a-47cf-8fbf-78a54cba09de.zip

Products#

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

DailyMed product names page 1 of 1 · 9 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
79847-00179847-001-01, 79847-001-00

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALCOHOL3K9958V90MACTIB
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE0A5MM307FCIACT
GLYCERINPDC6A3C0OXIACT
.ALPHA.-TOCOPHEROLH4N855PNZ1IACT
BUTYL ALCOHOL8PJ61P6TS3IACT
DENATONIUM BENZOATE4YK5Z54AT2IACT
DIISOPROPYLAMINEBR9JLI40NOIACT

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
74ec884d-155d-408a-98a9-9e353a168050daa3cc5c-5d0a-47cf-8fbf-78a54cba09de2020-09-04WarningsExact identifier
spl id: 74ec884d-155d-408a-98a9-9e353a168050
spl set id: daa3cc5c-5d0a-47cf-8fbf-78a54cba09de

Reported adverse events (FAERS/openFDA)#

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