PREPIEL K365 CLEAN TISSUE- alcohol cloth

Prepiel K365 CLEAN TISSUE by

Drug Labeling and Warnings

Prepiel K365 CLEAN TISSUE 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 61.52% w/w .................................Antiseptic

Use

• Sanitizer tissue 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

■ Use one or several sheets to rub well and 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, Glycerin, Citric Acid, Sodium Citrate, Polysorbate 80, Fragrance

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

PREPIEL K365 CLEAN TISSUE 
alcohol cloth

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 90028-060
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	2.3 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
SODIUM CITRATE (UNII: 1Q73Q2JULR)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 90028-060-01	20 in 1 PACKET; 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(90028-060)