PURE FINE MEDIWIPER

Manufacturer
Hyosung SP Co.,Ltd | FIRSTCHAM CO., LTD
Effective date
2020-04-24
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:07:33

Label at a glance#

ProductPURE FINE MEDIWIPER
Active ingredientBENZALKONIUM CHLORIDE
Label structure10 sections

Indications and uses

Uses: ■ instant healthcare personnel hand antiseptic to reduce bacteria that potentially can cause disease ■ instant hand antiseptic to decrease bacteria on the skin

Dosage and administration

Directions: ■ Scrub and wipe off the hand and skin, which are used individually or if necessary ■ Clean with wipes and let dry

Label contents#

Full prescribing information#

ACTIVE INGREDIENT

OTC - ACTIVE INGREDIENT SECTION

Active Ingredients: Benzalkonium Chloride 0.1%

INACTIVE INGREDIENT

INACTIVE INGREDIENT SECTION

Inactive Ingredients:

Water, Glycerin, Sodium benzoate, Polysorbate 20, Disodium EDTA, Phenoxyethanol, Tocopheryl acetate, Citric acid

PURPOSE

OTC - PURPOSE SECTION

Purpose: antiseptic

KEEP OUT OF REACH OF CHILDREN

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.

Uses

INDICATIONS & USAGE SECTION

Uses:

■ instant healthcare personnel hand antiseptic to reduce bacteria that potentially can cause disease
■ instant hand antiseptic to decrease bacteria on the skin

WARNINGS

WARNINGS SECTION

Warnings

For external use only. Flammable. Keep away from heat or flame
--------------------------------------------------------------------------------------------------------
Do not use
• in combination with soap or antibacterial cleansing agents
• the product for a long time in the same area as swelling, inflammation or sickness may occur due to absorption through the skin. It is not recommended to use this one areas that have been medically treated with a cast or bandage
--------------------------------------------------------------------------------------------------------
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 hypersensitivity symptoms such as erythema, itching and dermatitis happen or skin irritation happens.

Directions

DOSAGE & ADMINISTRATION SECTION

Directions:

■ Scrub and wipe off the hand and skin, which are used individually or if necessary
■ Clean with wipes and let dry

Other information

OTHER SAFETY INFORMATION

Other information:

• Store between 15-30C (59-86F)
• Avoid freezing and excessive heat above 40C (104F)

Package Label - PURE FINE MEDIWIPER 108g, 20ct

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Image of containerImage of container

Package Label - PURE FINE MEDIWIPER 432g, 80ct

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Image of containerImage of container

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
76522-010-012022-01-28C16284748780-1d6a99b39-3ae0-a426-e053-dadaa90af4c2Drug Facts
76522-010-022022-01-28C16284748780-1d6a99b39-3ae0-a426-e053-dadaa90af4c2Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76522-010-01PURE FINE MEDIWIPER108 g in 1 CONTAINERLIQUID1081
76522-010-02PURE FINE MEDIWIPER432 g in 1 CONTAINERLIQUID4321

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76522-010PURE FINE MEDIWIPER (BENZALKONIUM CHLORIDE) LIQUID [HYOSUNG SP CO.,LTD]1Legacy NDC, 2 package rows20200424_0a4ddfeb-33c9-47b6-8699-812b65ea5dbb.zip

Products#

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

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
76522-01076522-010-01, 76522-010-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Source Document#

Source XML · Source PDF

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
2458032a-9a5c-443d-91a3-ee3f7f287fba0a4ddfeb-33c9-47b6-8699-812b65ea5dbb2020-04-24WarningsExact identifier
spl id: 2458032a-9a5c-443d-91a3-ee3f7f287fba
spl set id: 0a4ddfeb-33c9-47b6-8699-812b65ea5dbb

Reported adverse events (FAERS/openFDA)#

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