CLEAN IT FRESH WATER GE L- alcohol gel

CLEAN IT FRESH WATER GE L by

Drug Labeling and Warnings

CLEAN IT FRESH WATER GE L by is a Otc medication manufactured, distributed, or labeled by ARIA COSMETIC CO., LTD.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Alcohol

INACTIVE INGREDIENT

Carbomer, Dipropylene glycol, Fragrance, Glycerin, Green tea extract, Polysorbate 80, Purified water, Triethanolamine

PURPOSE

Antiseptic
Instant hand sanitizer to decrease bacteria on the skin

INDICATIONS & USAGE

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

■ 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.

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

When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.

STOP USE

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.

STORAGE AND HANDLING

■ Store between 15-30℃ (59-86℉).
■ Avoid freezing and excessive heat above 40℃ (104℉).

DOSAGE & ADMINISTRATION

Pump 1-2 times and rub it into your hand. For topical use only.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

CLEAN IT FRESH WATER GE L 
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 75229-101
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)
GLYCERIN (UNII: PDC6A3C0OX)
TROLAMINE (UNII: 9O3K93S3TK)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
DIPROPYLENE GLYCOL (UNII: E107L85C40)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 75229-101-01	500 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	04/15/2020
2	NDC: 75229-101-02	30 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	04/14/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	04/14/2020

Labeler - ARIA COSMETIC CO., LTD. (694237552)

Registrant - ARIA COSMETIC CO., LTD. (694237552)

Establishment
Name	Address	ID/FEI	Business Operations
ARIA COSMETIC CO., LTD.		694237552	manufacture(75229-101)