FIRST HAND SANITIZER- alcohol gel 
Korea Life Science 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.

----------

ACTIVE INGREDIENT

ALCOHOL

INACTIVE INGREDIENT

glycerin carbomer, green tea extract, aloe extract, mugwort extract, L-menthol, triethanolamine

PURPOSE

SANITIZER

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).

KEEP OUT OF REACH OF CHILDREN

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

Uses

Disinfection of hands and skin

Directions

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

label

FIRST HAND SANITIZER 
alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:74406-002
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL70 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
GLYCERIN (UNII: PDC6A3C0OX)  
GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
ARTEMISIA PRINCEPS LEAF (UNII: SY077EW02G)  
WATER (UNII: 059QF0KO0R)  
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
LEVOMENTHOL (UNII: BZ1R15MTK7)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:74406-002-01500 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product05/19/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A05/19/2020
Labeler - Korea Life Science Co.,ltd (694914835)
Registrant - Korea Life Science Co.,ltd (694914835)
Establishment
NameAddressID/FEIBusiness Operations
Korea Life Science Co.,ltd694914835manufacture(74406-002)

Revised: 5/2020
Document Id: a5f94dec-fecf-ce46-e053-2a95a90a6286
Set id: a5f94552-5d1a-7950-e053-2995a90a3484
Version: 1
Effective Time: 20200518
 
Korea Life Science Co.,ltd