GUDETAMA MOISTURIZING HAND SANITIZER PEACH- 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.

----------

ACTIVE INGREDIENT

Ethyl alcohol 70%

INACTIVE INGREDIENT

Aqua/Water, Carbomer, Aminomethyl Propanol, Jasminum Officinale (Jasmine) Extract, Prunus Mume Flower Extract, Bellis Perennis (Daisy) Flower Extract, Fragrance, Aloe Barbadensis Extract, Tocopheryl Acetate, CI 15985

PURPOSE

Antiseptic

WARNINGS

For external use only: hands

--------------------------------------------------------------------------------------------------------

Flammable. Keep away from fire or flame
--------------------------------------------------------------------------------------------------------
When using this product

ㆍkeep out of eyes. In case of contact with eyes, flush thoroughly with water.
ㆍavoid contact with broken skin ㆍdo not inhale or ingest
--------------------------------------------------------------------------------------------------------
Stop use and ask a doctor if 

ㆍirritation or redness develops ㆍcondition persists for more than 72 hours

KEEP OUT OF REACH OF CHILDREN

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

Uses

ㆍto decrease bacteria on the skin that could cause disease
ㆍrecommended for repeated use

Directions

ㆍwet hands thoroughly with product and allow to dry without wiping
ㆍfor children under 6, use only under adult supervision
ㆍnot recommended for infants
ㆍdo not consume

Other Information

ㆍstore below 110℉ (43℃) ㆍmay discolor some fabrics
ㆍharmful to wood finishes and plastics

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Image of pouch

GUDETAMA MOISTURIZING HAND SANITIZER PEACH 
ethyl alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:75010-120
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Alcohol (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) Alcohol21 mL  in 30 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:75010-120-0130 mL in 1 POUCH; Type 0: Not a Combination Product08/01/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E08/01/2020
Labeler - Mirfeel Korea Co., Ltd (695004258)
Registrant - Mirfeel Korea Co., Ltd (695004258)
Establishment
NameAddressID/FEIBusiness Operations
Mirfeel Korea Co., Ltd695004258manufacture(75010-120)

Revised: 8/2020
Document Id: eba48c22-cea5-444f-946d-e97889b2c4f2
Set id: 08a80c14-f188-428a-aca1-f19dc0b636a8
Version: 1
Effective Time: 20200811
 
Mirfeel Korea Co., Ltd