FDA.reportPublic FDA data

Hand Sanitizer

Manufacturer
Supplyaid Rapid Response | SUMEC Hardware & Tools Co. Ltd. | Supplyaid Rapid Response LLC
Effective date
2021-11-23
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:45:04

Label at a glance#

ProductHand Sanitizer
Active ingredientALCOHOL
Label structure13 sections

Dosage and administration

Remove wipe from package. Reseal package to keep wipes from drying out. Then apply wipe to hands and clean thoroughly. 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#

SPL UNCLASSIFIED SECTION

Product is hand sanitizing wipes

  1. Alcohol (ethanol) (USP or Food Chemical Codex (FCC) grade) (80%, volume/volume (v/v)) in an aqueous solution denatured according to Alcohol and Tobacco Tax and Trade Bureau regulations in 27 CFR part 20.
  2. Glycerol.
  3. Sosium Hyaluronate.
  4. Aloe extract
  5. Trolamine
  6. Water.
  7. Denatorium

Active Ingredient(s)

OTC - ACTIVE INGREDIENT SECTION

IngredientsIngredientsAlcohol 80% v/v. Purpose: Antiseptic

Purpose

OTC - PURPOSE SECTION

Antiseptic, Hand Sanitizer

Use

INDICATIONS & USAGE SECTION

Sanitizing wipes er 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

  • on children less than 2 months of age
  • on damaged or sensitive skin

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

  • Remove wipe from package. Reseal package to keep wipes from drying out. Then apply wipe to hands and clean thoroughly.
  • 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

glycerol, aloe extract, sodium hyaluronate, trolamine, wtaer, denatonium

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Carton PackageCarton PackagePouch PackagePouch PackageNDC: 74251-205-11

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2361646ethanol 80 % Medicated PadPSN2
2361646ethanol 0.8 ML/ML Medicated PadSCD2
2361646ethanol 80 % Medicated WipesSY2
2361646ethyl alcohol 80 % Topical ClothSY2

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
74251-205-112023-01-30C16284748780-1f386c649-dd17-0266-e053-dadaa90a7c1ab3e879fa-e414-4e0f-e053-2a95a90aa344

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
74251-205-11Hand Sanitizer50 mL in 1 POUCHCLOTH502

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
74251-205HAND SANITIZER (ALCOHOL) CLOTH [SUPPLYAID RAPID RESPONSE]2Legacy NDC, 1 package rows20211124_b3e879fa-e414-4e0f-e053-2a95a90aa344.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
74251-20574251-205-11

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
WATER059QF0KO0RIACT
ALCOHOL3K9958V90MACTIB
ALOEV5VD430YW9IACT
GLYCERINPDC6A3C0OXIACT
DENATONIUM4IK22DF4OUIACT
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
d17b6cf7-790a-cd32-e053-2a95a90a4767b3e879fa-e414-4e0f-e053-2a95a90aa3442021-11-23WarningsExact identifier
spl id: d17b6cf7-790a-cd32-e053-2a95a90a4767
spl set id: b3e879fa-e414-4e0f-e053-2a95a90aa344

Reported adverse events (FAERS/openFDA)#

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