FDA.reportPublic FDA data

Hand 2 Hand Sanitizer

Manufacturer
ASI Chemical, Inc.
Effective date
2021-12-14
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 23:45:39

Label at a glance#

ProductHand 2 Hand Sanitizer
Active ingredientISOPROPYL ALCOHOL
Label structure12 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

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Isopropyl Alcohol 70%

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 heat or flame

Do not use

OTC - DO NOT USE SECTION

Do not use with children less than 2 months of age. On open wounds or broken skin.

When using this product

OTC - WHEN USING SECTION

keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.

Stop use and ask a doctor

OTC - STOP USE SECTION

Stop use and ask a doctor if irritation or rash occurs. 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

OTHER SAFETY INFORMATION

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

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Water (Aqua), Carbomer, Glycerin, Trolamine

Hand 2 Hand Sanitizer

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

labellabellabellabellabellabellabellabellabellabel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
581698isopropyl alcohol 70 % Topical GelPSN3
581698isopropyl alcohol 0.7 ML/ML Topical GelSCD3
581698isopropyl alcohol 70 % Topical GelSY3

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
78437-100-022023-01-30C16284748780-1f386c64a-337c-0266-e053-dadaa90a7c1aHand 2 Hand Sanitizer
78437-100-042023-01-30C16284748780-1f386c64a-337c-0266-e053-dadaa90a7c1aHand 2 Hand Sanitizer
78437-100-082023-01-30C16284748780-1f386c64a-337c-0266-e053-dadaa90a7c1aHand 2 Hand Sanitizer
78437-100-372023-01-30C16284748780-1f386c64a-337c-0266-e053-dadaa90a7c1aHand 2 Hand Sanitizer
78437-100-642023-01-30C16284748780-1f386c64a-337c-0266-e053-dadaa90a7c1aHand 2 Hand Sanitizer

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
78437-100-02Hand 2 Hand Sanitizer60 mL in 1 BOTTLEGEL603
78437-100-04Hand 2 Hand Sanitizer120 mL in 1 BOTTLEGEL1203
78437-100-08Hand 2 Hand Sanitizer236 mL in 1 BOTTLEGEL2363
78437-100-37Hand 2 Hand Sanitizer3785 mL in 1 BOTTLEGEL37853
78437-100-64Hand 2 Hand Sanitizer1892.71 mL in 1 BOTTLEGEL1892.713

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
78437-100HAND 2 HAND SANITIZER (ISOPROPYL ALCOHOL 70%) GEL [ASI CHEMICAL, INC.]3Legacy NDC, 5 package rows20211215_a79890fd-e49a-03db-e053-2995a90a6292.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
78437-10078437-100-02, 78437-100-04, 78437-100-08, 78437-100-37, 78437-100-64

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
CARBOMER 9404Q93RCW27EIACT
TROLAMINE9O3K93S3TKIACT
ISOPROPYL ALCOHOLND2M416302ACTIB
WATER059QF0KO0RIACT
GLYCERINPDC6A3C0OXIACT

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
d31d6493-8e87-0419-e053-2a95a90a2aafa79890fd-e49a-03db-e053-2995a90a62922021-12-14WarningsExact identifier
spl id: d31d6493-8e87-0419-e053-2a95a90a2aaf
spl set id: a79890fd-e49a-03db-e053-2995a90a6292