HYUNDAE MEDITECH BIO HAIR SOLU TION ERUA DO- allantoin solution

HYUNDAE MEDITECH BIO HAIR SOLU TION ERUA DO by

Drug Labeling and Warnings

HYUNDAE MEDITECH BIO HAIR SOLU TION ERUA DO by is a Otc medication manufactured, distributed, or labeled by INNOGENE CO.,LTD. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredient: Allantoin 0.95%

INACTIVE INGREDIENT

Inactive Ingredients: Water, Glycerin, Butylene Glycol, Methylparaben, Phenoxyethanol, Sorbitol, Glycogen, Copper Tripeptide-1, Mannitol, Pterocarpus Marsupium Bark Extract, Serenoa Serrulata Fruit Extract, Ammonium Glycyrrhizate, Disodium Succinate, Eriobotrya Japonica Leaf Extract, Glutamic Acid, Caffeine, Zinc Gluconate, Aesculus Hippocastanum (Horse Chestnut) Seed Extract

PURPOSE

Purpose: Scalp Protectant

WARNINGS

Warnings: 1. If the following symptoms occur after product use, stop using the product immediately and consult a dermatologist (continuous use can exacerbate the symptoms): a) Red spots, swelling, itchiness, and other skin irritation b) If the symptoms above occur after the application area is exposed to direct sunlight. 2. Do not use on open wounds, eczema, and other skin irritations. 3. Storing and handling a) Close the lid after every use. b) Keep out of reach of infants and children. c) Do not store at extreme temperatures or in an area exposed to direct sunlight. 4. Wash away immediately when permeating into the eyes.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of infants and children.

INDICATIONS & USAGE

Indications & usage: 1. Wash scalp tholoughly before product use. 2. Shake the product. 3. Take appropriate amount out of a container and rub on parts of scalp in trouble to absorb enough.

DOSAGE & ADMINISTRATION

Dosage & Administration: One time per week, 5cc for one use

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

HYUNDAE MEDITECH BIO HAIR SOLU TION ERUA DO 
allantoin solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70540-030
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Allantoin (UNII: 344S277G0Z) (ALLANTOIN - UNII:344S277G0Z)	Allantoin	0.04 g  in 5 g

Inactive Ingredients
Ingredient Name	Strength
Water (UNII: 059QF0KO0R)
Glycerin (UNII: PDC6A3C0OX)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70540-030-02	12 in 1 CARTON	08/20/2016
1	NDC: 70540-030-01	5 g in 1 VIAL; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part347	08/20/2016

Labeler - INNOGENE CO.,LTD (688201056)

Registrant - INNOGENE CO.,LTD (688201056)

Establishment
Name	Address	ID/FEI	Business Operations
INNOGENE CO.,LTD		688201056	manufacture(70540-030)