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

  • Category: HUMAN OTC DRUG LABEL

DISCLAIMER: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

Drug Label Information

Updated July 13, 2019

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  • 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

    label

  • INGREDIENTS AND APPEARANCE
    BOTANETH PRONOXIN HAIR REGAINER FS2 ACTIVATOR 2-A 2-B 
    allantoin kit
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73199-0002
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:73199-0002-11 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/13/2019
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 11 BOTTLE, PLASTIC 60 mL
    Part 21 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 AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALLANTOIN (UNII: 344S277G0Z) (ALLANTOIN - UNII:344S277G0Z) ALLANTOIN0.1 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:73199-0004-160 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other07/13/2019
    Part 2 of 2
    BOTANETH PRONOXIN HAIR REGAINER FS2 ACTIVATOR 2-A 
    allantoin liquid
    Product Information
    Item Code (Source)NDC:73199-0003
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALLANTOIN (UNII: 344S277G0Z) (ALLANTOIN - UNII:344S277G0Z) ALLANTOIN0.1 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:73199-0003-160 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other07/13/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other07/13/2019
    Labeler - OUIBON GLOBAL (695029852)
    Registrant - OUIBON GLOBAL (695029852)
    Establishment
    NameAddressID/FEIBusiness Operations
    LABIO Co., Ltd.689845457manufacture(73199-0002)
    Establishment
    NameAddressID/FEIBusiness Operations
    OUIBON GLOBAL695029852label(73199-0002)