FDA.reportPublic FDA data

ALCOHOL WIPES

Manufacturer
WENZHOU GUANGSEN PAPER CO., LTD.
Effective date
2020-10-27
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-05-31 23:32:34

Label at a glance#

ProductALCOHOL WIPES
Active ingredientALCOHOL
Label structure13 sections

Dosage and administration

Wipe the surface of the skin 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#

SPL UNCLASSIFIED SECTION

ALCOHOL WIPES

Active Ingredient(s)

OTC - ACTIVE INGREDIENT SECTION

1mL/pcs. Purpose: Antiseptic

Purpose

OTC - PURPOSE SECTION

Antiseptic, ALCOHOL WIPES

Use

INDICATIONS & USAGE SECTION

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 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

purified water USP

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

010102020303040405050606070708080909101011111212131314141515

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
78369-101-012022-01-28C16284748780-1d6a99b39-63e2-a426-e053-dadaa90af4c2ALCOHOL WIPES
78369-101-022022-01-28C16284748780-1d6a99b39-63e2-a426-e053-dadaa90af4c2ALCOHOL WIPES
78369-101-032022-01-28C16284748780-1d6a99b39-63e2-a426-e053-dadaa90af4c2ALCOHOL WIPES
78369-101-042022-01-28C16284748780-1d6a99b39-63e2-a426-e053-dadaa90af4c2ALCOHOL WIPES
78369-101-052022-01-28C16284748780-1d6a99b39-63e2-a426-e053-dadaa90af4c2ALCOHOL WIPES
78369-101-062022-01-28C16284748780-1d6a99b39-63e2-a426-e053-dadaa90af4c2ALCOHOL WIPES
78369-101-072022-01-28C16284748780-1d6a99b39-63e2-a426-e053-dadaa90af4c2ALCOHOL WIPES
78369-101-082022-01-28C16284748780-1d6a99b39-63e2-a426-e053-dadaa90af4c2ALCOHOL WIPES
78369-101-092022-01-28C16284748780-1d6a99b39-63e2-a426-e053-dadaa90af4c2ALCOHOL WIPES
78369-101-102022-01-28C16284748780-1d6a99b39-63e2-a426-e053-dadaa90af4c2ALCOHOL WIPES
78369-101-112022-01-28C16284748780-1d6a99b39-63e2-a426-e053-dadaa90af4c2ALCOHOL WIPES
78369-101-122022-01-28C16284748780-1d6a99b39-63e2-a426-e053-dadaa90af4c2ALCOHOL WIPES
78369-101-132022-01-28C16284748780-1d6a99b39-63e2-a426-e053-dadaa90af4c2ALCOHOL WIPES
78369-101-142022-01-28C16284748780-1d6a99b39-63e2-a426-e053-dadaa90af4c2ALCOHOL WIPES
78369-101-152022-01-28C16284748780-1d6a99b39-63e2-a426-e053-dadaa90af4c2ALCOHOL WIPES

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
78369-101-01ALCOHOL WIPES10 in 1 BAGCLOTH104
78369-101-02ALCOHOL WIPES50 in 1 BAGCLOTH504
78369-101-03ALCOHOL WIPES60 in 1 CYLINDERCLOTH604
78369-101-04ALCOHOL WIPES100 in 1 CYLINDERCLOTH1004
78369-101-05ALCOHOL WIPES50 in 1 BAGCLOTH504
78369-101-06ALCOHOL WIPES1 in 1 BAGCLOTH14
78369-101-07ALCOHOL WIPES80 in 1 BAGCLOTH804
78369-101-08ALCOHOL WIPES100 in 1 BAGCLOTH1004
78369-101-09ALCOHOL WIPES120 in 1 BAGCLOTH1204
78369-101-10ALCOHOL WIPES50 in 1 BAGCLOTH504
78369-101-11ALCOHOL WIPES10 in 1 BAGCLOTH104
78369-101-12ALCOHOL WIPES160 in 1 CANISTERCLOTH1604
78369-101-13ALCOHOL WIPES200 in 1 CANISTERCLOTH2004
78369-101-14ALCOHOL WIPES60 in 1 CANISTERCLOTH604
78369-101-15ALCOHOL WIPES100 in 1 CANISTERCLOTH1004

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
78369-101ALCOHOL WIPES (ALCOHOL) CLOTH [WENZHOU GUANGSEN PAPER CO., LTD.]4Legacy NDC, 15 package rows20201029_a67a0de1-279c-7ec9-e053-2995a90a45a8.zip

Products#

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

DailyMed product names page 1 of 1 · 3 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
78369-10178369-101-01, 78369-101-02, 78369-101-03, 78369-101-04, 78369-101-05, 78369-101-06, 78369-101-07, 78369-101-08, 78369-101-09, 78369-101-10, 78369-101-11, 78369-101-12, 78369-101-13, 78369-101-14, 78369-101-15

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 2 matching rows.

Name, UNII, Kind table
NameUNIIKind
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
b2b28dd0-c4ac-36fa-e053-2a95a90adad1a67a0de1-279c-7ec9-e053-2995a90a45a82020-10-27WarningsExact identifier
spl id: b2b28dd0-c4ac-36fa-e053-2a95a90adad1
spl set id: a67a0de1-279c-7ec9-e053-2995a90a45a8

Reported adverse events (FAERS/openFDA)#

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