FDA.reportPublic FDA data

75% alcohol wipes

Manufacturer
Shandong Yayun Sanitary Products Co., Ltd.
Effective date
2023-10-20
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-05-31 23:57:08

Label at a glance#

Product75% alcohol wipes
Active ingredientALCOHOL
Label structure13 sections

Dosage and administration

Wipe the surface of the skin and let it dry naturally 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

75% alcohol wipes

Active Ingredient(s)

OTC - ACTIVE INGREDIENT SECTION

Alcohol 1mL/pcs. Purpose: Antiseptic

Purpose

OTC - PURPOSE SECTION

Antiseptic, 75% alcohol wipes

Use

INDICATIONS & USAGE SECTION

75% alcohol wipes 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

  • Wipe the surface of the skin and let it dry naturally
  • 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

WATER
Benzalkonium Chloride
Glycerol

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

labellabel

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
79539-501-012025-01-30C16284748780-12cef2736-ab61-d83d-e063-dadaa90ab31f75% alcohol wipes
79539-501-022025-01-30C16284748780-12cef2736-ab61-d83d-e063-dadaa90ab31f75% alcohol wipes
79539-501-032025-01-30C16284748780-12cef2736-ab61-d83d-e063-dadaa90ab31f75% alcohol wipes
79539-501-042025-01-30C16284748780-12cef2736-ab61-d83d-e063-dadaa90ab31f75% alcohol wipes
79539-501-052025-01-30C16284748780-12cef2736-ab61-d83d-e063-dadaa90ab31f75% alcohol wipes
79539-501-062025-01-30C16284748780-12cef2736-ab61-d83d-e063-dadaa90ab31f75% alcohol wipes

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
79539-501-0175% alcohol wipes10 in 1 BAGCLOTH104
79539-501-0275% alcohol wipes20 in 1 BAGCLOTH204
79539-501-0375% alcohol wipes50 in 1 BAGCLOTH504
79539-501-0475% alcohol wipes60 in 1 BAGCLOTH604
79539-501-0575% alcohol wipes80 in 1 BAGCLOTH804
79539-501-0675% alcohol wipes100 in 1 BAGCLOTH1004

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
79539-50175% ALCOHOL WIPES (ALCOHOL) CLOTH [SHANDONG YAYUN SANITARY PRODUCTS CO., LTD.]4Legacy NDC, 6 package rows20231021_aeb9ec70-a601-99a7-e053-2995a90ab22a.zip

Products#

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

DailyMed product names page 1 of 1 · 5 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
79539-50179539-501-01, 79539-501-02, 79539-501-03, 79539-501-04, 79539-501-05, 79539-501-06

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 4 matching rows.

Name, UNII, Kind table
NameUNIIKind
GLYCERINPDC6A3C0OXIACT
BENZALKONIUM CHLORIDEF5UM2KM3W7IACT
WATER059QF0KO0RIACT
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
08239e85-eb3f-c257-e063-6394a90a5274aeb9ec70-a601-99a7-e053-2995a90ab22a2023-10-20WarningsExact identifier
spl id: 08239e85-eb3f-c257-e063-6394a90a5274
spl set id: aeb9ec70-a601-99a7-e053-2995a90ab22a

Reported adverse events (FAERS/openFDA)#

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