NEW CLEAN HAND SANITIZER- alcohol gel

New Clean Hand Sanitizer by

Drug Labeling and Warnings

New Clean Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by U2, HEALKINBIO CO.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

ALCOHOL 62% v/v

INACTIVE INGREDIENT

Water, Triethanolamine, Polysorbate 20, Glycerin, Carbomer, Camellia Sinensis Leaf Extract, Tocopheryl Acetate, Fragrance

PURPOSE

Antiseptic

WARNINGS

Warnings:

For external use only. Flammable. Keep away from heat or flame
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Do not use
in children less than 2 months of age
on open skin wounds
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When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.
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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.

Uses

■ instant hand antiseptic to decrease bacteria on the skin
■ recommended for repeated use

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 1~30℃
■ Avoid freezing and excessive heat above 40℃ (104F)

Questions?

■ +82-10-2863-2511 (Mon. to Fri. 10 AM-5 PM)

PACKAGE LABEL : New Clean Hand Sanitizer 60mL

PACKAGE LABEL : New Clean Hand Sanitizer 500mL

INGREDIENTS AND APPEARANCE

NEW CLEAN HAND SANITIZER 
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 78023-010
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	62 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
Water (UNII: 059QF0KO0R)
TROLAMINE (UNII: 9O3K93S3TK)
Polysorbate 20 (UNII: 7T1F30V5YH)
Glycerin (UNII: PDC6A3C0OX)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 78023-010-01	60 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	05/01/2020
2	NDC: 78023-010-02	500 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	05/01/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	05/01/2020

Labeler - U2 (695538837)

Registrant - U2 (695538837)

Establishment
Name	Address	ID/FEI	Business Operations
HEALKINBIO CO.		694039685	manufacture(78023-010)