FDA.reportPublic FDA data

Alcohol Hand Wipes

Manufacturer
Fuson LLC | OLCE GROUP KOZMETIK KIMYA GIDA MEDIKAL VE SAGLIK URUNLERI SANAYI VE TICARET LTD STI
Effective date
2020-08-21
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:29:25

Label at a glance#

ProductAlcohol Hand Wipes
Active ingredientALCOHOL
Label structure12 sections

Storage and handling

Keep away from direct sunlight. Store tightly closed in its original packaging and in a cool, dry place. Keep away from food, drinks, and animal feed. Store away from reach of children.

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Ethyl Alcohol (Ethanol) 70%

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Aqua, glycerin, peg-7 glyceryl cocoate, polysorbate 20, cocamidopropyl betaine, dexpanthenol, citrus limon peel, citric acid, EDTA

Purpose

OTC - PURPOSE SECTION

Antiseptic- Antibacterial hand towelettes

Use

INDICATIONS & USAGE SECTION

Wipes used on hands and skin to reduce bacteria

Warnings

WARNINGS SECTION

For external use only, do not ingest. Do not use near eyes. Keep away from flame and direct sunlight. Do not eat, drink, or smoke during use. If irritation or redness occurs and persists for longer than 72 hours, consult a medical professional.

Do Not Use

OTC - DO NOT USE SECTION

Do not use near eyes. Do not ingest. Do not eat, smoke, or drink during use. Do not use on or in open skin wounds. Do not use on children under 2 months of age.

When Using

OTC - WHEN USING SECTION

If ingested, contact a poison control center immediately. If eye contact occurs, flush eyes with water repeatidly.

Stop Use

OTC - STOP USE SECTION

Stop use if redness, irritation, or rash occurs.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Store in places out of reach of children. Supervise use by children under the age of 6.

Dierctions

DOSAGE & ADMINISTRATION SECTION

Peel back open label slowly. Pull out one wipe at a time and re-seal the packaging tightly. Wet hands thoroughly with product and allow to dry without wiping.

Storage

STORAGE AND HANDLING SECTION

Keep away from direct sunlight. Store tightly closed in its original packaging and in a cool, dry place. Keep away from food, drinks, and animal feed. Store away from reach of children.

Package Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

120 Count Canister: 78141-211-12

200 Count Canister: 78141-211-20

500 Count Canister: 78141-211-50

78141-211-2078141-211-20

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1489307ethanol 70 % Medicated PadPSN1
1489307ethanol 0.7 ML/ML Medicated PadSCD1
1489307ethanol 70 % Medicated PadSY1
1489307ethanol 70 % Medicated WipesSY1
1489307ethyl alcohol 70 % ClothSY1

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
777d68c6-a5ab-e06c-d314-677b0b9af0c8Product name220240508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
78141-211-122022-01-28C16284748780-1d6a99b39-46ac-a426-e053-dadaa90af4c2ad654143-1c44-51c1-e053-2a95a90a1b7b
78141-211-202022-01-28C16284748780-1d6a99b39-46ac-a426-e053-dadaa90af4c2ad654143-1c44-51c1-e053-2a95a90a1b7b
78141-211-502022-01-28C16284748780-1d6a99b39-46ac-a426-e053-dadaa90af4c2ad654143-1c44-51c1-e053-2a95a90a1b7b

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
78141-211-12Alcohol Hand Wipes524.4 mL in 1 CANISTERCLOTH524.41
78141-211-20Alcohol Hand Wipes874 mL in 1 CANISTERCLOTH8741
78141-211-50Alcohol Hand Wipes2185 mL in 1 CANISTERCLOTH21851

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
78141-211ALCOHOL HAND WIPES (ETHYL ALCOHOL) CLOTH [FUSON LLC]1Legacy NDC, 3 package rows20200916_ad654143-1c44-51c1-e053-2a95a90a1b7b.zip

Products#

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

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
78141-21178141-211-50, 78141-211-20, 78141-211-12

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Name, UNII, Kind table
NameUNIIKind
DEXPANTHENOL1O6C93RI7ZIACT
PEG-7 GLYCERYL COCOATEVNX7251543IACT
EDETIC ACID9G34HU7RV0IACT
ANHYDROUS CITRIC ACIDXF417D3PSLIACT
WATER059QF0KO0RIACT
POLYSORBATE 207T1F30V5YHIACT
COCAMIDOPROPYL BETAINE5OCF3O11KXIACT
LEMON OIL, DISTILLEDET5GD00TRPIACT
GLYCERINPDC6A3C0OXIACT
ALCOHOL3K9958V90MACTIB

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
ad654143-1c45-51c1-e053-2a95a90a1b7bad654143-1c44-51c1-e053-2a95a90a1b7b2020-08-21WarningsExact identifier
spl id: ad654143-1c45-51c1-e053-2a95a90a1b7b
spl set id: ad654143-1c44-51c1-e053-2a95a90a1b7b

Reported adverse events (FAERS/openFDA)#

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