PREPIEL K365 CLEAN GEL- alcohol gel

Prepiel K365 CLEAN Gel by

Drug Labeling and Warnings

Prepiel K365 CLEAN Gel by is a Otc medication manufactured, distributed, or labeled by JMB COSLINE CO.,LTD. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

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

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

PREPIEL K365 CLEAN GEL 
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 90028-070
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	350 mL  in 500 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
CARBOMER INTERPOLYMER TYPE A (55000 CPS) (UNII: 59TL3WG5CO)
TROLAMINE (UNII: 9O3K93S3TK)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 90028-070-01	500 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	02/09/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	02/09/2021

Labeler - JMB COSLINE CO.,LTD (694837486)

Establishment
Name	Address	ID/FEI	Business Operations
JMB COSLINE CO.,LTD		694837486	manufacture(90028-070)