MEDIKOII BIO SAFE HAND REFRESHING- alcohol gel

MEDIKOii Bio Safe Hand Refreshing by

Drug Labeling and Warnings

MEDIKOii Bio Safe Hand Refreshing by is a Otc medication manufactured, distributed, or labeled by THERANOTICS CO.,LTD., BIO-FD&C. Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

INGREDIENTS AND APPEARANCE

MEDIKOII BIO SAFE HAND REFRESHING 
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72695-0014
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	62 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72695-0014-1	100 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	06/01/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	06/01/2020

Labeler - THERANOTICS CO.,LTD. (694963085)

Registrant - THERANOTICS CO.,LTD. (694963085)

Establishment
Name	Address	ID/FEI	Business Operations
BIO-FD&C. Co., Ltd.		688203268	manufacture(72695-0014)