Active Ingredient
Alcohol 70% w/w .................................Antiseptic
Prepiel K365 Clean Gel
FDA Label NDC 90028-070
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Jmb Cosline Co.,ltd for the product Prepiel K365 Clean Gel (NDC 90028-070). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredient, use, warnings, do not use, when using this product, stop use and ask a doctor, keep out of reach of children, directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Use
- Hand Sanitizer to help reduce bacteria that potentially can cause disease.
- For use when soap and water are not available.
Warnings
For external use only. Flammable. Keep away from heat or flame.
Do Not Use
■ in children less than 2 months 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 a serious condition.
Keep Out Of Reach Of Children
If swallowed, get medical help or contact a Poison Control Center right away.
Directions
■ 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.
Other Information
■ Store between 15-30 °C (59-86 °F)
■ Avoid freezing and excessive heat above 40 °C (104 °F)
Inactive Ingredients
Water, Butylene Glycol, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Carbomer,
Triethanolamine, Fragrance
* Please review the disclaimer below.
