Label: BOTANETH PRONOXIN HAIR REGAINER- zinc pyrithione, salicylic acid shampoo
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Contains inactivated NDC Code(s)
NDC Code(s): 73199-0001-1 - Packager: OUIBON GLOBAL
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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.
Drug Label Information
Updated July 13, 2019
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
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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
- KEEP OUT OF REACH OF CHILDREN
- INDICATIONS & USAGE
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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
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
BOTANETH PRONOXIN HAIR REGAINER
zinc pyrithione, salicylic acid shampooProduct 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)
