FDA.reportPublic FDA data

Hand Sanitizing Wipes

Manufacturer
SUMEC Hardware & Tools Co., Ltd. | A03 Lab of BTS
Effective date
2020-09-03
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:26:49

Label at a glance#

ProductHand Sanitizing Wipes
Active ingredientALCOHOL
Label structure12 sections

Dosage and administration

Remove wipe from package. Reseal package to prevent 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 59-86℉ (15-30℃) Avoid freezing and excessive heat above 104℉ (40℃)

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Ethyl alcohol 80% v/v. Purpose: Antiseptic

Purpose

OTC - PURPOSE SECTION

Antiseptic

Use

INDICATIONS & USAGE SECTION

Sanitizing wipes to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

Warnings

WARNINGS SECTION

Flammable. Keep away from heat or flame. For external use only. Not for use as a baby wipe.

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.

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 prevent 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 59-86℉ (15-30℃)
  • Avoid freezing and excessive heat above 104℉ (40℃)

Inactive ingredients

INACTIVE INGREDIENT SECTION

Glycerol, Aloe extract, Sodium Hyaluronate, Trolamine, Water (aqua), Denatonium

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Principal Display PanelPrincipal Display PanelPouchPouchCartonCarton

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
74035-2051-22022-01-28C16284748780-1d6a99b39-7b39-a426-e053-dadaa90af4c2SUMEC, Wipes, 80% Ethyl alcohol, 50*4

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
74035-2051-1Hand Sanitizing Wipes50 in 1 POUCHCLOTH501
74035-2051-2Hand Sanitizing Wipes4 in 1 CARTONCLOTH41

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
74035-2051HAND SANITIZING WIPES (ALCOHOL) CLOTH [SUMEC HARDWARE & TOOLS CO., LTD.]1Legacy NDC, 2 package rows20200904_ae6d905c-ca6e-15a2-e053-2995a90a0641.zip

Products#

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

DailyMed product names page 1 of 1 · 8 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
74035-205174035-2051-1, 74035-2051-2

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
ALOE VERA LEAFZY81Z83H0XIACT
TROLAMINE9O3K93S3TKIACT
WATER059QF0KO0RIACT
ALCOHOL3K9958V90MACTIB
GLYCERINPDC6A3C0OXIACT
HYALURONATE SODIUMYSE9PPT4THIACT
DENATONIUM BENZOATE ANHYDROUSM5BA6GAF1OIACT

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
ae6d905c-ca6f-15a2-e053-2995a90a0641ae6d905c-ca6e-15a2-e053-2995a90a06412020-09-03WarningsExact identifier
spl id: ae6d905c-ca6f-15a2-e053-2995a90a0641
spl set id: ae6d905c-ca6e-15a2-e053-2995a90a0641

Reported adverse events (FAERS/openFDA)#

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