BOTANETH PRONOXIN HAIR REGAINER- zinc pyrithione, salicylic acid shampoo 
OUIBON GLOBAL

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Drug Facts

zinc pyrithione, salicylic acid

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

Protect scalp, hair loss prevention

keep out of reach of the children

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)

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.

for topical use only

label

BOTANETH PRONOXIN HAIR REGAINER 
zinc pyrithione, salicylic acid shampoo
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73199-0001
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID0.2 g  in 100 mL
PYRITHIONE ZINC (UNII: R953O2RHZ5) (PYRITHIONE ZINC - UNII:R953O2RHZ5) PYRITHIONE ZINC0.3 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:73199-0001-1200 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/13/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart358H07/13/2019
Labeler - OUIBON GLOBAL (695029852)
Registrant - OUIBON GLOBAL (695029852)
Establishment
NameAddressID/FEIBusiness Operations
Ester Co., Ltd.688425766manufacture(73199-0001)
Establishment
NameAddressID/FEIBusiness Operations
OUIBON GLOBAL695029852label(73199-0001)

Revised: 7/2019
Document Id: 8d8c866f-91a1-d361-e053-2995a90a9f0d
Set id: 8d8a6908-caae-65b5-e053-2995a90a1bb6
Version: 2
Effective Time: 20190713
 
OUIBON GLOBAL