BOTANETH PRONOXIN HAIR REGAINER FS2 ACTIVATOR 2-A 2-B- allantoin kit

BOTANETH PRONOXIN HAIR REGAINER FS2 ACTIVATOR 2-A 2-B by

Drug Labeling and Warnings

BOTANETH PRONOXIN HAIR REGAINER FS2 ACTIVATOR 2-A 2-B by is a Otc medication manufactured, distributed, or labeled by OUIBON GLOBAL, LABIO Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

ALLANTOIN

INACTIVE INGREDIENT

2-A - Water, Alcohol, Butylene Glycol, Glycyrrhiza
Glabra (Licorice) Root Extract, Octanediol, Allantoin,
Sodium hydroxide, Ethylhexylglycerin, Ascorbic
acid, Menthol, Disodium EDTA, Maltodextrin,
Fragaria Chiloensis (Strawberry) Fruit Extract, Citrus
Grandis (Grapefruit) Seed Extract, Nonfat Dry Milk,
Glucose, Fructose, Sodium chloride, Cinnamon
Cassia Bark Extract, Artemisia Princeps Extract

2-B - Water, Alcohol, Butylene Glycol, Curcuma
Longa (Turmeric) Root Extract, Octanediol,
Allantoin, Ethylhexylglycerin, Menthol, Disodium
EDTA, Citric acid, Casein, Dextrin, Maltodextrin,
Glucose, Citrus Grandis (Grapefruit) Seed Extract,
Fructose, Potassium phosphate, Tricalcium
phosphate, Dipotassium phosphate, Artemisia
Princeps Extract

PURPOSE

Protect scalp, hair loss prevention

KEEP OUT OF REACH OF CHILDREN

keep out of reach of the children

INDICATIONS & USAGE

1.After shampoo, spray activator 2-A & 2-B on scalp one by one.

2. Massage scalp gently 3. Wait at least 30 minutes then rinse off.

WARNINGS

for external use only. If irritation develops, discontinue use.

DOSAGE & ADMINISTRATION

for topical use only

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

BOTANETH PRONOXIN HAIR REGAINER FS2 ACTIVATOR 2-A 2-B 
allantoin kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73199-0002

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73199-0002-1	1 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	07/13/2019

Quantity of Parts
Part #	Package Quantity	Total Product Quantity
Part 1	1 BOTTLE, PLASTIC	60 mL
Part 2	1 BOTTLE, PLASTIC	60 mL

Part 1 of 2

BOTANETH PRONOXIN HAIR REGAINER FS2 ACTIVATOR 2-B 
allantoin liquid

Product Information
Item Code (Source)	NDC: 73199-0004
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALLANTOIN (UNII: 344S277G0Z) (ALLANTOIN - UNII:344S277G0Z)	ALLANTOIN	0.1 g  in 100 mL

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73199-0004-1	60 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		07/13/2019

Part 2 of 2

BOTANETH PRONOXIN HAIR REGAINER FS2 ACTIVATOR 2-A 
allantoin liquid

Product Information
Item Code (Source)	NDC: 73199-0003
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALLANTOIN (UNII: 344S277G0Z) (ALLANTOIN - UNII:344S277G0Z)	ALLANTOIN	0.1 g  in 100 mL

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73199-0003-1	60 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		07/13/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		07/13/2019

Labeler - OUIBON GLOBAL (695029852)

Registrant - OUIBON GLOBAL (695029852)

Establishment
Name	Address	ID/FEI	Business Operations
LABIO Co., Ltd.		689845457	manufacture(73199-0002)

Establishment
Name	Address	ID/FEI	Business Operations
OUIBON GLOBAL		695029852	label(73199-0002)