BOTANETH PRONOXIN HAIR REGAINER- zinc pyrithione, salicylic acid shampoo

BOTANETH PRONOXIN HAIR REGAINER by

Drug Labeling and Warnings

BOTANETH PRONOXIN HAIR REGAINER by is a Otc medication manufactured, distributed, or labeled by OUIBON GLOBAL, Ester Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

zinc pyrithione, salicylic acid

INACTIVE INGREDIENT

Water, Sodium Laureth Sulfate, Cocamidopropyl Betaine, Sodium Chloride, Cocamide MIPA, Isopropanolamine, Zinc Pyrithione, Sodium Polynaphthalenesulfonate, Panthenol, Pantolactone, Menthol, Isopulegol, Polyquaternium-10, Pinus Sylvestris Leaf Extract, Pentylene Glycol, Caprylyl Glycol, Butylene Glycol, Eucalyptus Globulus Leaf Oil, Mentha Arvensis Leaf Oil, Amyris Balsamifera Bark Oil, Eucalyptus Globulus Leaf Oil, Litsea Cubeba Fruit Oil, Lavandula Angustifolia (Lavender) Oil, Citrus Aurantium Dulcis (Orange) Peel Oil, Salicylic Acid, Chlorphenesin, Citric Acid, Disodium EDTA, Artemisia Vulgaris Extract, Curcuma Longa (Turmeric) Root Extract, Angelica Gigas Root Extract, Astragalus Membranaceus Root Extract, Acorus Gramineus Root/Stem Extract, Ginkgo Biloba Leaf Extract, Morus Bombycis Leaf Extract, Panax Ginseng Root Extract, 1,2-Hexanediol, Glycerin, Copper Tripeptide-1, Rehmannia Glutinosa Root Extract, Cornus Officinalis Fruit Extract, Dioscorea Japonica Root Extract, Alisma Orientale Tuber Extract, Poria Cocos Sclerotium Extract, Paeonia Suffruticosa Root Extract, Ethylhexylglycerin

PURPOSE

Protect scalp, hair loss prevention

KEEP OUT OF REACH OF CHILDREN

keep out of reach of the children

INDICATIONS & USAGE

1. APPLY TO WET HAIR WITH WARM WATER AND MASSAGE SCALP GENTLY.

2. WAIT 3 MINUTES THEN RINSE OFF (3. USE ACTIVATOR AFTER DRYING HAIR)

WARNINGS

1. In case of using cosmetics or after use, please consult a specialist if there is any abnormal symptom or side effect such as red spot, swelling or itching in direct sunlight.
2. Do not use on wounded areas.
3. In case of contact with eyes, wash immediately.
4. Care should be taken not to rinse with water after use, as it may cause hair loss or discoloration.

DOSAGE & ADMINISTRATION

for topical use only

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

BOTANETH PRONOXIN HAIR REGAINER 
zinc pyrithione, salicylic acid shampoo

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73199-0001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ)	SALICYLIC ACID	0.2 g  in 100 mL
PYRITHIONE ZINC (UNII: R953O2RHZ5) (PYRITHIONE ZINC - UNII:R953O2RHZ5)	PYRITHIONE ZINC	0.3 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: 73199-0001-1	200 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	07/13/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part358H	07/13/2019

Labeler - OUIBON GLOBAL (695029852)

Registrant - OUIBON GLOBAL (695029852)

Establishment
Name	Address	ID/FEI	Business Operations
Ester Co., Ltd.		688425766	manufacture(73199-0001)

Establishment
Name	Address	ID/FEI	Business Operations
OUIBON GLOBAL		695029852	label(73199-0001)