FDA.reportPublic FDA data

Kwork Ethanol disinfection gel

Manufacturer
Zhejiang Quark Biotechnology Co., Ltd.
Effective date
2020-06-30
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:19:42

Label at a glance#

ProductKwork Ethanol disinfection gel
Active ingredientALCOHOL
Label structure12 sections

Dosage and administration

Place enough product on hands to cover all surfaces. Rub hands together 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#

Active Ingredient(s)

OTC - ACTIVE INGREDIENT SECTION

Alcohol 75% w/w. Purpose: Antiseptic

Purpose

OTC - PURPOSE SECTION

Antiseptic, Hand Sanitizer

Use

INDICATIONS & USAGE SECTION

Hand Sanitizer 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

  • Place enough product on hands to cover all surfaces. Rub hands together 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

Carbomer, Triethanciamine, Essence, purified water USP

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

60 mL NDC: 78867-002-01 60ml package label60ml package label

100 mL NDC: 78867-002-02 100ml package label100ml package label

480mL NDC: 78867-002-03 480ml package label480ml package label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1305100ethanol 75 % Topical GelPSN1
1305100ethanol 0.75 ML/ML Topical GelSCD1
1305100ethanol 75 % Topical GelSY1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
78867-002-012021-07-23C16284748780-1c7ccaba7-2328-fd44-e053-dadaa90aa01ba949dcff-70da-2b43-e053-2a95a90a52df
78867-002-022021-07-23C16284748780-1c7ccaba7-2328-fd44-e053-dadaa90aa01ba949dcff-70da-2b43-e053-2a95a90a52df
78867-002-032021-07-23C16284748780-1c7ccaba7-2328-fd44-e053-dadaa90aa01ba949dcff-70da-2b43-e053-2a95a90a52df

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
78867-002-01Kwork Ethanol disinfection gel60 mL in 1 BOTTLEGEL601
78867-002-02Kwork Ethanol disinfection gel100 mL in 1 BOTTLEGEL1001
78867-002-03Kwork Ethanol disinfection gel480 mL in 1 BOTTLEGEL4801

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
78867-002KWORK ETHANOL DISINFECTION GEL (ALCOHOL) GEL [ZHEJIANG QUARK BIOTECHNOLOGY CO., LTD.]1Legacy NDC, 3 package rows20200701_a949dcff-70da-2b43-e053-2a95a90a52df.zip

Products#

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

DailyMed product names page 1 of 1 · 5 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
78867-00278867-002-01, 78867-002-02, 78867-002-03

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 4 matching rows.

Name, UNII, Kind table
NameUNIIKind
ACRYLIC ACIDJ94PBK7X8SIACT
TROLAMINE9O3K93S3TKIACT
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
a949a2d9-d9e9-7d6b-e053-2995a90a1e89a949dcff-70da-2b43-e053-2a95a90a52df2020-06-30WarningsExact identifier
spl id: a949a2d9-d9e9-7d6b-e053-2995a90a1e89
spl set id: a949dcff-70da-2b43-e053-2a95a90a52df

Reported adverse events (FAERS/openFDA)#

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