FDA.reportPublic FDA data

Alcohol wipes

Manufacturer
Jiangyin Yunzhi Medical Non-woven Products Co., Ltd
Effective date
2020-09-26
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:30:19

Label at a glance#

ProductAlcohol wipes
Active ingredientALCOHOL
Label structure12 sections

Dosage and administration

l.Remove lid. 2.Remove foil seal. 3.Pull wipes from centre of roll and thread through dispenser. 4.Ensure tab is closed after every use,to avoid evaporation. 5.Dispense wipes as needed.

Storage and handling

If the condition persists for more than 72 hours, consult a physician. Please close the lid after dispensing to maintain purity. Store below 95°F(35°C).

Label contents#

Full prescribing information#

Active Ingredient(s)

OTC - ACTIVE INGREDIENT SECTION

Ethyl alcohol 75% ..... antiseptic

Purpose

OTC - PURPOSE SECTION

Antiseptic, Hand Sanitizer

Use

INDICATIONS & USAGE SECTION

For external use only.

THESE WIPES DO NOT REPLACE WIPES USED FOR MEDICAL PROCEDURES.
THESE WIPES ARE MEANT FOR GENERAL CLEANSING.
Keep in a dry place away from fire.

Warnings

WARNINGS SECTION

For external use only.
THESE WIPES DO NOT REPLACE WIPES USED FOR MEDICAL PROCEDURES.
THESE WIPES ARE MEANT FOR GENERAL CLEANSING.
Keep in a dry place away from fire.

Keep this out of reach of children.
If swallowed,get medical help or contact a Poison Control Center immediately.

Do not use in or contact the eyes.
Discontinue use if irritation and redness develop.

If the condition persists for more than 72 hours, consult a physician.
Please close the lid after dispensing to maintain purity.

Store below 95°F(35°C).

Do not use

OTC - DO NOT USE SECTION

THESE WIPES DO NOT REPLACE WIPES USED FOR MEDICAL PROCEDURES.
THESE WIPES ARE MEANT FOR GENERAL CLEANSING.

Do not use in or contact the eyes.
Discontinue use if irritation and redness develop.

OTC - WHEN USING SECTION

Keep in a dry place away from fire.

Keep this out of reach of children.
If swallowed,get medical help or contact a Poison Control Center immediately.

Do not use in or contact the eyes.
Discontinue use if irritation and redness develop.

OTC - STOP USE SECTION

/

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep this out of reach of children.
If swallowed,get medical help or contact a Poison Control Center immediately.

Directions

DOSAGE & ADMINISTRATION SECTION

l.Remove lid.
2.Remove foil seal.
3.Pull wipes from centre of roll and thread through dispenser.
4.Ensure tab is closed after every use,to avoid evaporation.
5.Dispense wipes as needed.

Other information

STORAGE AND HANDLING SECTION

If the condition persists for more than 72 hours, consult a physician.
Please close the lid after dispensing to maintain purity.

Store below 95°F(35°C).

Inactive ingredients

INACTIVE INGREDIENT SECTION

Purified Water,Glycerin,Benzalkonium Chloride, Aloe Barbadensis Leaf Extract

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

80538-001-03 750P80538-001-03 750P80538-001-01 60P80538-001-01 60P80538-001-02 320P80538-001-02 320P

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
80538-001-012021-07-23C16284748780-1c7ccaba7-1524-fd44-e053-dadaa90aa01b80538-001 Alcohol wipes
80538-001-022021-07-23C16284748780-1c7ccaba7-1524-fd44-e053-dadaa90aa01b80538-001 Alcohol wipes
80538-001-032021-07-23C16284748780-1c7ccaba7-1524-fd44-e053-dadaa90aa01b80538-001 Alcohol wipes

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80538-001-01Alcohol wipes60 in 1 BAGCLOTH601
80538-001-02Alcohol wipes320 in 1 BAGCLOTH3201
80538-001-03Alcohol wipes750 in 1 BAGCLOTH7501

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80538-001ALCOHOL WIPES CLOTH [JIANGYIN YUNZHI MEDICAL NON-WOVEN PRODUCTS CO., LTD]1Legacy NDC, 3 package rows20200927_b0422782-6b87-2f66-e053-2a95a90ac55e.zip

Products#

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

DailyMed product names page 1 of 1 · 6 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
80538-00180538-001-01, 80538-001-02, 80538-001-03

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 5 matching rows.

Name, UNII, Kind table
NameUNIIKind
GLYCERINPDC6A3C0OXIACT
BENZALKONIUM7N6JUD5X6YIACT
WATER059QF0KO0RIACT
ALCOHOL3K9958V90MACTIB
ALOE VERA LEAFZY81Z83H0XIACT

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
b041da68-bf49-dad7-e053-2a95a90a22c6b0422782-6b87-2f66-e053-2a95a90ac55e2020-09-26WarningsExact identifier
spl id: b041da68-bf49-dad7-e053-2a95a90a22c6
spl set id: b0422782-6b87-2f66-e053-2a95a90ac55e

Reported adverse events (FAERS/openFDA)#

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