RISUA HAND SANITIZER ETHANOL- alcohol gel 
Dasol 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 Ingredients 

Active ingredients: ALCOHOL 62.00%

INACTIVE INGREDIENT

Inactive ingredients:

Water, Glycerin, Carbomer, Polysorbate 80, Triethanolamine

Purpose

Purpose: SANITIZER

Warnings

Warnings:

Flammable. Keep away from fire or flame.
For external use only
Stop use and ask a doctor if irritation of redness develops and persist
Keep out of reach of children
In case of accidental digestion, seek professional assistance or contact a poison control center immediately

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. 

Uses

Uses:

To help remove bacteria and germs on the skin

Directions

Directions:

Please enough product in palm to cover hands and rub hands together briskly until dry.
Not recommended for infants.

PACKAGE LABEL - RISUA HAND SANITIZER(ETHANOL) 500mL Bottle

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PACKAGE LABEL - RISUA HAND SANITIZER(ETHANOL) 25mL Container

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PACKAGE LABEL - RISUA HAND SANITIZER(ETHANOL) 1.5mL Pouch

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RISUA HAND SANITIZER ETHANOL 
alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73758-010
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL62.0 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
Water (UNII: 059QF0KO0R)  
Glycerin (UNII: PDC6A3C0OX)  
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
Polysorbate 80 (UNII: 6OZP39ZG8H)  
TROLAMINE (UNII: 9O3K93S3TK)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:73758-010-01500 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product03/01/2020
2NDC:73758-010-0225 mL in 1 CONTAINER; Type 0: Not a Combination Product03/01/2020
3NDC:73758-010-031.5 mL in 1 POUCH; Type 0: Not a Combination Product03/01/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E03/01/2020
Labeler - Dasol Co.,ltd. (557839013)
Registrant - Dasol Co.,ltd. (557839013)
Establishment
NameAddressID/FEIBusiness Operations
Dasol Co.,ltd.557839013manufacture(73758-010)

Revised: 3/2020
Document Id: c69762af-5e62-448f-8b81-eb67e20043ed
Set id: 31861eb2-b5a8-40d7-a3ab-e91208affaff
Version: 1
Effective Time: 20200327
 
Dasol Co.,ltd.