K-PURE HAND SANITIZER 70% 500ML- ethyl alcohol gel

K-pure Hand Sanitizer 70% 500ml by

Drug Labeling and Warnings

K-pure Hand Sanitizer 70% 500ml by is a Otc medication manufactured, distributed, or labeled by Metapola Aroma Co., Ltd., Metapola Aroma Co., Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient(s)

Ethyl Alcohol 70% v/v

Purpose

Antiseptic

Use

Health care personnel hand rub to help reduce bacteria that potentially can cause disease.

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

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

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.

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.

Other information

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

Inactive ingredients

Water, Methyl Gluceth-20, PEG-60 Hydrogenated Castor Oil, Tocopheryl Acetate, Aloe Barbadensis Leaf Extract, Hyaluronic Acid, Aminomethyl Propanol, Fragrance

Questions or Comments?

1-800-461-5824

Package Label - Principal Display Panel

K-Pure

HAND

SANITIZER

70% Alcohol

MOISTURIZING FORMULA

VITAMIN E

ALOE VERA

16.9 fl.oz (500ml)

INGREDIENTS AND APPEARANCE

K-PURE HAND SANITIZER 70% 500ML 
ethyl alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 77680-100
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	70 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
ALOE VERA LEAF (UNII: ZY81Z83H0X)
WATER (UNII: 059QF0KO0R)
HYALURONIC ACID (UNII: S270N0TRQY)
PEG-60 HYDROGENATED CASTOR OIL (UNII: 02NG325BQG)
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)
METHYL GLUCETH-20 (UNII: J3QD0LD11P)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 77680-100-01	500 mL in 1 BOTTLE; Type 0: Not a Combination Product	07/14/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	07/14/2020

Labeler - Metapola Aroma Co., Ltd. (690311712)

Establishment
Name	Address	ID/FEI	Business Operations
Metapola Aroma Co., Ltd		690311712	manufacture(77680-100) , label(77680-100)