BIOPURE 250CT ANTI BACTERIAL HAND WIPES

Manufacturer
Zhejiang Furuisen Spunlaced Nonwovens Co., Ltd.
Effective date
2024-08-28
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 00:18:03

Key Label Information#

Active Ingredients And Purpose

Active ingredient

Benzalkonium Chloride 0.12% ……………………………………………...Antibacterial

OTC - PURPOSE SECTION

●For use when soap and water are not available.

Uses

Uses

●Hand sanitizer to help reduce bacteria

Warnings

Warnings

For external use only.

Do not use

●in children less than 2 months old. ●on open skin wounds

Stop use and ask a doctor

if irritation or rash occurs. These may be signs of a serious condition

Directions And Dosage

Directions

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

Other Label 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

Glycerin, Phenoxyethanol, Propylene Glycol, Water

79794-900-01

79794-900-02

Label Images#

900
900
900-02
900-02

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1038741benzalkonium Cl 0.12 % Medicated PadPSN3
1038741benzalkonium chloride 1.2 MG/ML Medicated PadSCD3
1038741benzalkonium chloride 0.12 % Medicated WipeSY3
1038741benzalkonium chloride 0.12 % Topical ClothSY3
1038741benzalkonium chloride 0.12 % Topical SwabSY3

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
79794-900-012024-02-01C16284748780-11030e365-5c7f-111a-e063-dadaa90a10e279794-900

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
79794-900-01BIOPURE 250CT ANTI BACTERIAL HAND WIPES1 in 1 BOXCLOTH13
79794-900-01BIOPURE 250CT ANTI BACTERIAL HAND WIPES12 in 1 CANISTERCLOTH123
79794-900-02BIOPURE 250CT ANTI BACTERIAL HAND WIPES6 in 1 CANISTERCLOTH63
79794-900-02BIOPURE 250CT ANTI BACTERIAL HAND WIPES1 in 1 BOXCLOTH13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
79794-900BIOPURE 250CT ANTI BACTERIAL HAND WIPES (BENZALKONIUM CHLORIDE) CLOTH [ZHEJIANG FURUISEN SPUNLACED NONWOVENS CO., LTD.]3Legacy NDC, 4 package rows20240829_ee48c7f1-04ad-1663-e053-2995a90ae41e.zip

Products#

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
79794-90079794-900-01, 79794-900-02

Ingredients#

Complete SPL Sections#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Benzalkonium Chloride 0.12% ……………………………………………...Antibacterial

Uses

INDICATIONS & USAGE SECTION

●Hand sanitizer to help reduce bacteria

OTC - PURPOSE SECTION

OTC - PURPOSE SECTION

●For use when soap and water are not available.

Warnings

WARNINGS SECTION

For external use only.

Do not use

OTC - DO NOT USE SECTION

●in children less than 2 months old. ●on open skin wounds

When using this product

OTC - WHEN USING SECTION

keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.

Stop use and ask a doctor

OTC - STOP USE SECTION

if irritation or rash occurs. These may be signs of a serious condition

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

STORAGE AND HANDLING SECTION

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

Glycerin, Phenoxyethanol, Propylene Glycol, Water

Question?

POSTMARKETING EXPERIENCE SECTION

Call 718-975-2586

79794-900-01

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

79794-900-02

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Source Document#

Source XML