Biopure Antibacterial Hand Wipes

Manufacturer
Osike Cosmetics Co., Ltd.
Effective date
2022-01-20
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 23:47:15

Label at a glance#

ProductBiopure Antibacterial Hand Wipes
Active ingredientALCOHOL
Label structure12 sections

Dosage and administration

●Apply to hands, allow to air dry without wiping. ●Children under 6 years of age should be supervised when using this product

Storage and handling

●Store in a cool, dry place,between 15°-30°C(59°F-86°F)。 ●Avoid freezing and excessive heat above 40°C(104°F).

Label contents#

Full prescribing information#

Active Ingredient(s)

OTC - ACTIVE INGREDIENT SECTION

Ethyl Alcohol 75%

Purpose

OTC - PURPOSE SECTION

Antiseptic

Use

INDICATIONS & USAGE SECTION

●Hand sanitizer to help reduce bacteria
●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
●in children less than 2 mouths of age.
●on open skin wounds

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 serious condition.

Keep out of reach of children. If swallowed. get medical help or contact a Poison Control Center right away.

Do not use

OTC - DO NOT USE SECTION

Do not use
●in children less than 2 mouths 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 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 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

●Apply to hands, allow to air dry without wiping.
●Children under 6 years of age should be supervised when using this product

Other information

STORAGE AND HANDLING SECTION

●Store in a cool, dry place,between 15°-30°C(59°F-86°F)。
●Avoid freezing and excessive heat above 40°C(104°F).

Inactive ingredients

INACTIVE INGREDIENT SECTION

Purified water USP

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

79866-009-01 50p79866-009-01 50p

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1307051ethanol 75 % Medicated PadPSN3
1307051ethanol 0.75 ML/ML Medicated PadSCD3
1307051ethanol 75 % Hand Sanitizer WipesSY3
1307051ethyl alcohol 75 % Topical ClothSY3

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
79866-009-012024-01-30C16284748780-11030e365-3655-111a-e063-dadaa90a10e279866-009 Antibacterial Hand Wipes

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
79866-009-01Biopure Antibacterial Hand Wipes50 in 1 POUCHCLOTH503

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
79866-009BIOPURE ANTIBACTERIAL HAND WIPES CLOTH [OSIKE COSMETICS CO., LTD.]3Legacy NDC, 1 package rows20220120_aff5a7ef-5702-0d5d-e053-2a95a90ac53e.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
79866-00979866-009-01

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
d5fea031-f3df-3ca7-e053-2995a90a5977aff5a7ef-5702-0d5d-e053-2a95a90ac53e2022-01-20WarningsExact identifier
spl id: d5fea031-f3df-3ca7-e053-2995a90a5977
spl set id: aff5a7ef-5702-0d5d-e053-2a95a90ac53e

Reported adverse events (FAERS/openFDA)#

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