COSO HEALTH HAND SANITIZER GREEN TEA- ethyl alcohol gel 
Mirfeel 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

Ethyl alcohol 70%(w/w)

INACTIVE INGREDIENT

Water, Carbomer, Aminomethyl Propanol, Jasminum Officinale (Jasmine) Extract, Prunus Mume Flower Extract, Bellis Perennis (Daisy) Flower Extract, Aloe Barbadensis Extract, Tocopheryl Acetate

PURPOSE

ANTISEPTIC

WARNINGS

ㆍFor external use only.
ㆍFlammable. Keep away from fire or flame


ㆍDo not use
-in children less than 2 months of age
-on open skin wounds


ㆍWhen using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rins eyes thoroughly with water.


ㆍStop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.


ㆍKeep out of reach of children if swallowed, get medical help or contact a Poison Control Center right away.

KEEP OUT OF REACH OF CHILDREN

If swallowed, get medical help or contact a Poison Control Center right away.

Uses

ㆍTo decrease bacteria on hands.

Directions

ㆍPlease take out adequate amounts of gel on palm of your hand and rub your hands for 15 seconds at least.

Other Information

ㆍStore between 15-30℃ (59-86℉)
ㆍAvoid freezing and excessive heat above 40℃ (104℉)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Image of bottle

COSO HEALTH HAND SANITIZER  GREEN TEA
ethyl alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:75010-100
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Alcohol (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) Alcohol350 g  in 500 mL
Inactive Ingredients
Ingredient NameStrength
Water (UNII: 059QF0KO0R)  
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
AminomethylPropanol (UNII: LU49E6626Q)  
JASMINUM OFFICINALE FLOWER (UNII: 0Q8K841432)  
PRUNUS MUME FLOWER (UNII: 2N8872050J)  
BELLIS PERENNIS FLOWER (UNII: 26I94X9A1K)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:75010-100-01500 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product07/01/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E07/01/2020
Labeler - Mirfeel Korea Co., Ltd (695004258)
Registrant - Mirfeel Korea Co., Ltd (695004258)
Establishment
NameAddressID/FEIBusiness Operations
Mirfeel Korea Co., Ltd695004258manufacture(75010-100)

Revised: 8/2020
Document Id: f0755777-fe08-4d98-bca4-cba5a58783df
Set id: 9dbe60b4-71e1-456f-8a3c-c86de890f6f5
Version: 1
Effective Time: 20200804
 
Mirfeel Korea Co., Ltd