MEDIKOII BIO-REPAIR CICA- glycerin cream

MEDIKOii Bio-Repair CICA by

Drug Labeling and Warnings

MEDIKOii Bio-Repair CICA 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 INGREDIENT

Glycerin

INACTIVE INGREDIENT

Water, Niacinamide, Adenosine, etc.

PURPOSE

Skin protectant

KEEP OUT OF REACH OF CHILDREN

keep out of reach of the children

INDICATIONS & USAGE

Apply proper amount to the skin.

WARNINGS

1. Do not use in the following cases(Eczema and scalp wounds)
2.Side Effects
1)Due to the use of this druf if rash, irritation, itching and symptopms of hypersnesitivity occur dicontinue use and consult your phamacisr or doctor
3.General Precautions
1)If in contact with the eyes, wash out thoroughty with water If the symptoms are servere, seek medical advice immediately
2)This product is for exeternal use only. Do not use for internal use
4.Storage and handling precautions
1)If possible, avoid direct sunlight and store in cool and area of low humidity
2)In order to maintain the quality of the product and avoid misuse
3)Avoid placing the product near fire and store out in reach of children

DOSAGE & ADMINISTRATION

for external use only

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

MEDIKOII BIO-REPAIR CICA 
glycerin cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72695-0001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX)	GLYCERIN	4.555 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
ADENOSINE (UNII: K72T3FS567)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72695-0001-1	50 mL in 1 JAR; Type 0: Not a Combination Product	10/01/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part347	10/01/2018

Labeler - THERANOTICS CO.,LTD. (694963085)

Registrant - THERANOTICS CO.,LTD. (694963085)

Establishment
Name	Address	ID/FEI	Business Operations
BIO-FD&C. Co., Ltd.		688203268	manufacture(72695-0001)

Establishment
Name	Address	ID/FEI	Business Operations
THERANOTICS CO.,LTD.		694963085	relabel(72695-0001)