FDA.reportPublic FDA data

One Touch Hand Sanitizer Gel

Manufacturer
One Touch Medical Inc
Effective date
2020-07-17
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 23:21:48

Label at a glance#

ProductOne Touch Hand Sanitizer
Active ingredientALCOHOL
Label structure12 sections

Dosage and administration

Directions 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#

SPL UNCLASSIFIED SECTION

One Touch Hand Sanitizer Gel

Drug Facts

Purpose

OTC - PURPOSE SECTION

Antiseptic

Use

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.

When using this product

OTC - WHEN USING SECTION

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

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

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

Directions

  • 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.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Aloe barbadensis extract, Purified water, Aminomethyl Propanol, Carbomer, Glycerin

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Alcohol 70% v/v

Do not use

OTC - DO NOT USE SECTION

Do not use

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

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LabelLabelMade in Canada

LabelLabel

LabelLabel

LabelLabel

LabelLabel

LabelLabel

LabelLabelLabelLabel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
581662ethanol 70 % Topical GelPSN3
581662ethanol 0.7 ML/ML Topical GelSCD3
581662ethanol 70 % Topical GelSY3
581662ethyl alcohol 70 % Topical GelSY3

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
77301-604-512023-01-30C16284748780-1f386c64a-0cf6-0266-e053-dadaa90a7c1aOne Touch Hand Sanitizer Gel
77301-604-522023-01-30C16284748780-1f386c64a-0cf6-0266-e053-dadaa90a7c1aOne Touch Hand Sanitizer Gel
77301-604-532023-01-30C16284748780-1f386c64a-0cf6-0266-e053-dadaa90a7c1aOne Touch Hand Sanitizer Gel
77301-604-542023-01-30C16284748780-1f386c64a-0cf6-0266-e053-dadaa90a7c1aOne Touch Hand Sanitizer Gel
77301-604-552023-01-30C16284748780-1f386c64a-0cf6-0266-e053-dadaa90a7c1aOne Touch Hand Sanitizer Gel
77301-604-562023-01-30C16284748780-1f386c64a-0cf6-0266-e053-dadaa90a7c1aOne Touch Hand Sanitizer Gel
77301-604-572023-01-30C16284748780-1f386c64a-0cf6-0266-e053-dadaa90a7c1aOne Touch Hand Sanitizer Gel
77301-604-582023-01-30C16284748780-1f386c64a-0cf6-0266-e053-dadaa90a7c1aOne Touch Hand Sanitizer Gel

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
77301-604-51One Touch Hand Sanitizer60 mL in 1 BOTTLEGEL603
77301-604-52One Touch Hand Sanitizer250 mL in 1 BOTTLEGEL2503
77301-604-53One Touch Hand Sanitizer500 mL in 1 BOTTLEGEL5003
77301-604-54One Touch Hand Sanitizer1000 mL in 1 BOTTLEGEL10003
77301-604-55One Touch Hand Sanitizer19000 mL in 1 PAILGEL190003
77301-604-56One Touch Hand Sanitizer3790 mL in 1 JUGGEL37903
77301-604-57One Touch Hand Sanitizer3790 mL in 1 JUGGEL37903
77301-604-58One Touch Hand Sanitizer208198 mL in 1 DRUMGEL2081983

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
77301-604ONE TOUCH HAND SANITIZER (ALCOHOL) GEL [ONE TOUCH MEDICAL INC]3Legacy NDC, 8 package rows20200718_a60708b5-f199-20dd-e053-2a95a90a16cf.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
77301-60477301-604-51, 77301-604-52, 77301-604-53, 77301-604-54, 77301-604-55, 77301-604-56, 77301-604-57, 77301-604-58

Ingredients#

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

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

Name, UNII, Kind table
NameUNIIKind
GLYCERINPDC6A3C0OXIACT
WATER059QF0KO0RIACT
ALCOHOL3K9958V90MACTIB
ALOEV5VD430YW9IACT
AMINOMETHYLPROPANOLLU49E6626QIACT
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE0A5MM307FCIACT

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
aaada9fe-951c-3960-e053-2995a90ad178a60708b5-f199-20dd-e053-2a95a90a16cf2020-07-17WarningsExact identifier
spl id: aaada9fe-951c-3960-e053-2995a90ad178
spl set id: a60708b5-f199-20dd-e053-2a95a90a16cf

Reported adverse events (FAERS/openFDA)#

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