MEDIKOII BIO SAFE HAND REFRESHING- alcohol gel 
THERANOTICS 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

ACTIVE INGREDIENTS

ALCOHOL 62% v/v

INACTIVE INGREDIENTS

Water, Ecklonia Cava Extract, Sophora Flavescens Extract, Centaurea Cyanus Flower Extract, Borago Officinalis Extract, Lavandula Angustifolia (Lavender) Flower Extract, Chamomilla Recutita (Matricaria) Flower Extract, Salvia Sclarea (Clary) Extract, Hyacinthus Orientalis (Hyacinth) Extract, Carbomer, Butylene Glycol, Tromethamine, 1,2-Hexanediol, Fragrance

PURPOSE

ANTISEPTIC

WARNINGS

For external use only. Flammable. Keep away from heat or flame
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Do not use
• in children less than 2 months of age
• on open skin wounds
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When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.
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Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

KEEP OUT OF REACH OF CHILDREN

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

Uses

Hand sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

Directions

• Place enough product on hands to cover all surfaces. Rub hands together until dry.
• Supervise children under 6 years of age when using this product to avoid swallowing.

Other information

• Store between 15-30C (59-86F)
• Avoid freezing and excessive heat above 40C (104F)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Image of bottle

MEDIKOII BIO SAFE HAND REFRESHING 
alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72695-0014
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL62 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
Water (UNII: 059QF0KO0R)  
ECKLONIA CAVA (UNII: UXX2N5V39P)  
SOPHORA FLAVESCENS ROOT (UNII: IYR6K8KQ5K)  
CENTAUREA CYANUS FLOWER (UNII: QZ239038YC)  
BORAGO OFFICINALIS SEED (UNII: 2GXJ790US0)  
LAVANDULA ANGUSTIFOLIA SUBSP. ANGUSTIFOLIA FLOWER (UNII: 19AH1RAF4M)  
CHAMOMILE (UNII: FGL3685T2X)  
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
Butylene Glycol (UNII: 3XUS85K0RA)  
TROLAMINE (UNII: 9O3K93S3TK)  
1,2-Hexanediol (UNII: TR046Y3K1G)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:72695-0014-1100 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product06/01/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E06/01/2020
Labeler - THERANOTICS CO.,LTD. (694963085)
Registrant - THERANOTICS CO.,LTD. (694963085)
Establishment
NameAddressID/FEIBusiness Operations
BIO-FD&C. Co., Ltd.688203268manufacture(72695-0014)

Revised: 6/2020
Document Id: 3f08565a-ece9-46e1-ae8a-1e8741943125
Set id: 5bb85505-d60c-4c59-ae7a-cc6ebefd8ed4
Version: 1
Effective Time: 20200615
 
THERANOTICS CO.,LTD.