HANCHEONSOO HAND ANTISEPTIC- alcohol gel 
Opseve KOREA Co.,Ltd.

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

Active ingredients: ALCOHOL 63%

INACTIVE INGREDIENT

Inactive ingredients:

Water, Glycerin, Butylene Glycol, Camellia Sinensis Leaf Extract, Carbomer, Triethanolamine

PURPOSE

Purpose: SANITIZER

WARNINGS

Warnings:


1.Do not use the product on the following areas:
Around the eyes and ears, in the mouth, large body parts and damaged skin(Irritation may occur)

2.If you experience any of the following symptoms, discontinue use of the product immediately and consult a physician or pharmacist.
1) Hypersensitivity symptoms, e.g. rash, erythema, itchiness, and edema
2)Skin irritation symptoms

3.Other precautions
1) For external use only (do not swallow).
2) Avoid contact with eyes. If contact occurs, wash with clean water and consult a doctor or pharmacist.
3)Be careful not to inhale vapors in cases of extended or prolonged use. (Repeating inhaling of large amounts of ethanol vapor may cause irritation of the mucous membranes and headaches).
(Limited to ethanol-containing products)
4) If used repeatedly in the same area, care should be provided as the skin may become rough due to excessive oil removal.
5) Do not use sealed bandages, cast bandages, or packs as they may cause irritation.
6) Do not use this drug on the anal or vagina areas, or with hot packs, as it may cause irritation or chemical burns.
7) Use only for the intended purposes.

4.Precautions for storage
1) Keep away from direct sunlight and do not expose the product to heating devices or flame.
2) Keep out of reach of children and go to the hospital immediately if swallowed.
3) After use, close the lid completely to prevent the product from drying or foreign objects from getting inside the container.
4) Storing the product in a different container may cause accidents or deterioration of quality. Therefore, keep the product in its original container.

Dust or foreign substances may get on the product while using it.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children and go to the hospital immediately if swallowed.

Uses

Uses:
Disinfection of hands and skin

Directions

Directions:

Take an appropriate amount on your hands and rub thoroughly to dry.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Image of carton

HANCHEONSOO HAND ANTISEPTIC 
alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:74195-040
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL63 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
Water (UNII: 059QF0KO0R)  
Glycerin (UNII: PDC6A3C0OX)  
Butylene Glycol (UNII: 3XUS85K0RA)  
GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
TROLAMINE (UNII: 9O3K93S3TK)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:74195-040-021 in 1 CARTON03/01/2020
1NDC:74195-040-01100 mL in 1 CONTAINER; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E03/01/2020
Labeler - Opseve KOREA Co.,Ltd. (690048629)
Registrant - Opseve KOREA Co.,Ltd. (690048629)
Establishment
NameAddressID/FEIBusiness Operations
Opseve KOREA Co.,Ltd.690048629manufacture(74195-040)

Revised: 4/2020
Document Id: 0d7251f7-1a82-4e91-adba-69778ab2b607
Set id: 4fc66ae8-eaa5-424d-88b6-8618bb949d26
Version: 1
Effective Time: 20200407
 
Opseve KOREA Co.,Ltd.