Prepiel K365 CLEAN Gel

Manufacturer
JMB COSLINE CO.,LTD
Effective date
2021-02-09
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:38:02

Label at a glance#

ProductPrepiel K365 CLEAN Gel
Active ingredientALCOHOL
Label structure11 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. ■ Avoid direct inhalation of vapors during application. (Headaches and irritation to mucous membranes may occur when directly inhaled.) ■ This product is intended only for hand sanitizing. ■ To prevent contents from drying out and contaminants f...

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Alcohol 70% w/w .................................Antiseptic

Use

OTC - PURPOSE 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

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

INDICATIONS & USAGE 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.
■ Avoid direct inhalation of vapors during application.

(Headaches and irritation to mucous membranes may occur when directly inhaled.)
■ This product is intended only for hand sanitizing.
■ To prevent contents from drying out and contaminants from entering, close
lid completely after use.
■ Keep product in its original container as storing the product in anything other than

the original container may result in accidents or cause the integrity of the product to diminish.
■ Do not use over bandages, castings, etc. as irritation may occur.

DOSAGE & ADMINISTRATION SECTION

Other information

OTHER SAFETY INFORMATION

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

Inactive ingredients

INACTIVE INGREDIENT SECTION

Water, Butylene Glycol, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Carbomer,
Triethanolamine, Fragrance

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Prepiel K365 CLEAN GELPrepiel K365 CLEAN GEL

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
581662ethanol 70 % Topical GelPSN1
581662ethanol 0.7 ML/ML Topical GelSCD1
581662ethanol 70 % Topical GelSY1
581662ethyl alcohol 70 % Topical GelSY1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
90028-070-012023-01-30C16284748780-1f386c64a-367f-0266-e053-dadaa90a7c1aJMB COSLINE CO.,LTD - ​Prepiel K365 CLEAN GEL 90028-070-01 500 mL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
90028-070-01Prepiel K365 CLEAN Gel500 mL in 1 BOTTLE, PUMPGEL5001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
90028-070PREPIEL K365 CLEAN GEL (ALCOHOL) GEL [JMB COSLINE CO.,LTD]1Legacy NDC, 1 package rows20210211_bae78489-6589-7ad4-e053-2a95a90a1fed.zip

Products#

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

DailyMed product names page 1 of 1 · 7 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
90028-07090028-070-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 6 matching rows.

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
bae78489-658a-7ad4-e053-2a95a90a1fedbae78489-6589-7ad4-e053-2a95a90a1fed2021-02-09WarningsExact identifier
spl id: bae78489-658a-7ad4-e053-2a95a90a1fed
spl set id: bae78489-6589-7ad4-e053-2a95a90a1fed

Reported adverse events (FAERS/openFDA)#

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