FDA.reportPublic FDA data

Hand Sanitizer Antimicrobial Hand Rub

Manufacturer
GATE THERAPEUTICS
Effective date
2021-11-10
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:44:53

Label at a glance#

ProductHand Sanitizer Antimicrobial Hand Rub
Active ingredientALCOHOL
Label structure12 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

Alcohol 70% v/v. Purpose: Antiseptic

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

Do not use

OTC - DO NOT USE SECTION

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

OTC - WHEN USING SECTION

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

OTC - STOP USE SECTION

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

Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Aminomethyl Propanol, Glycerin, Tocopheryl Acetate, Water

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Gaate Therapeutics

Hand Sanitizer

Antimicrobial Hand Rub

8 FL OZ / 237mL

Gate Hand Sanitizer LabelGate Hand Sanitizer Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
582753ethanol 70 % Topical SolutionPSN2
582753ethanol 0.7 ML/ML Topical SolutionSCD2
582753ethanol 70 % Topical SolutionSY2
582753ethyl alcohol 70 % Topical SolutionSY2

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
72274-003-012023-01-30C16284748780-1f386c64a-0caa-0266-e053-dadaa90a7c1aHand Sanitizer Antimicrobial Hand Rub
72274-003-022023-01-30C16284748780-1f386c64a-0caa-0266-e053-dadaa90a7c1aHand Sanitizer Antimicrobial Hand Rub
72274-003-032023-01-30C16284748780-1f386c64a-0caa-0266-e053-dadaa90a7c1aHand Sanitizer Antimicrobial Hand Rub

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72274-003-01Hand Sanitizer Antimicrobial Hand Rub60 mL in 1 BOTTLESOLUTION602
72274-003-02Hand Sanitizer Antimicrobial Hand Rub30 mL in 1 TUBESOLUTION302
72274-003-03Hand Sanitizer Antimicrobial Hand Rub237 mL in 1 BOTTLESOLUTION2372

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72274-003HAND SANITIZER ANTIMICROBIAL HAND RUB (ALCOHOL) SOLUTION [GATE THERAPEUTICS]2Legacy NDC, 3 package rows20211112_a5a36246-b297-3e17-e053-2995a90a9865.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
72274-00372274-003-01, 72274-003-02, 72274-003-03

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
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
GLYCERINPDC6A3C0OXIACT
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED)59TL3WG5COIACT
WATER059QF0KO0RIACT
ALCOHOL3K9958V90MACTIB
AMINOMETHYLPROPANOLLU49E6626QIACT

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
d075395e-bac5-2eb8-e053-2995a90a3ea3a5a36246-b297-3e17-e053-2995a90a98652021-11-10WarningsExact identifier
spl id: d075395e-bac5-2eb8-e053-2995a90a3ea3
spl set id: a5a36246-b297-3e17-e053-2995a90a9865

Reported adverse events (FAERS/openFDA)#

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