NEW CLEAN HAND SANITIZER- alcohol gel 
U2

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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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

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PACKAGE LABEL : New Clean Hand Sanitizer 500mL

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NEW CLEAN HAND SANITIZER 
alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:78023-010
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL62 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:78023-010-0160 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product05/01/2020
2NDC:78023-010-02500 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product05/01/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E05/01/2020
Labeler - U2 (695538837)
Registrant - U2 (695538837)
Establishment
NameAddressID/FEIBusiness Operations
HEALKINBIO CO.694039685manufacture(78023-010)

Revised: 5/2020
Document Id: f3996a7d-000c-4630-847b-99d598a7425a
Set id: f9ffcc60-aa6b-43d6-9131-b23d88b3fd40
Version: 1
Effective Time: 20200520
 
U2