COSMERIT HAND SANITIZER 1G- alcohol gel 
Interkos 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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Drug Facts

Alcohol

Water, Carbomer, Triethanolamine, PEG-60 Hydrogenated Castor Oil, Fragrance, Chlorphenesin, Trideceth-10, Butylene Glycol, Origanum Vulgare Leaf Extract, Chamaecyparis Obtusa Leaf Extract, Salix Alba (Willow) Bark Extract, Cinnamomum Cassia Bark Extract, Lactobacillus/Soybean Ferment Extract, Portulaca Oleracea Extract, Vincetoxicum Atratum Extract, Scutellaria Baicalensis Root Extract, 1,2-Hexanediol, Caprylyl Glycol, Aloe Barbadensis Leaf Extract, Illicium Verum (Anise) Fruit Extract

■ instant healthcare personnel hand antiseptic to reduce bacteria that potentially can cause disease

■ instant hand antiseptic to decrease bacteria on the skin

KEEP OUT OF REACH OF THE CHILDREN

Pump an appropriate amount on to the hands and rub together until dry

1. Do not use this product on the following parts of body. Around eyes and ears, oral cavity, large area of the
parts of body, or wounded skins (It may cause irritations)
2. Stop using at once in case of the following symptoms, and seek medical advice. 1) When eczema, red spots,
itchiness, edema, and allergic reactions occur. 2)When skin irritations happen.
3. Other user reminders 1) For external use only(No oral intake). 2) Avoid contact with eyes, and in case contact
occurs, rinse it thoroughly with clean water and consult a doctor or pharmacist. 3) When you use it on a large skin
area or use it long-termly, please be aware that vapor is not absorbed. (If Ethanol vapor is largely and repeatedly
inhaled and absorbed, it may cause irritation to mucous membrane and headache might occur.) 4)When the product
is used on the same part of skin repeatedly, the skin may become rough due to skimming. 5) Do not use with sealed
gauze bandage, Gibbs bandage or pack, as irritations may occur. 6) Do not use this product while anus and vagina
steaming as irritations or chemical burns may occur. 7) Do not use for purposes other than specified.

external use only

label

COSMERIT HAND SANITIZER 1G 
alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:77049-0003
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
PEG-60 HYDROGENATED CASTOR OIL (UNII: 02NG325BQG)  
WATER (UNII: 059QF0KO0R)  
CARBOMER 934 (UNII: Z135WT9208)  
TROLAMINE (UNII: 9O3K93S3TK)  
CHLORPHENESIN (UNII: I670DAL4SZ)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:77049-0003-13785 mL in 1 CONTAINER; Type 0: Not a Combination Product07/04/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E07/04/2020
Labeler - Interkos Co.,Ltd. (689850314)
Registrant - Interkos Co.,Ltd. (689850314)
Establishment
NameAddressID/FEIBusiness Operations
Interkos Co.,Ltd.689850314manufacture(77049-0003)

Revised: 7/2020
Document Id: a999f808-2e05-c9ff-e053-2995a90a8ff3
Set id: a99a0dca-9037-4d1b-e053-2995a90aff5b
Version: 1
Effective Time: 20200704
 
Interkos Co.,Ltd.