Label: BARBIUX BALSAMIC TONIC 5%- minoxidil solution

  • NDC Code(s): 71761-260-60
  • Packager: Incredible Products, S.A. de C.V.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated July 3, 2019

If you are a consumer or patient please visit this version.

  • Active ingredient:

    Minoxidil 5% w/v

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  • Purpose:

    Hair regrowth treatment for men

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  • Use:

    combat hair loss by reviving your hair follicles so you can safely and effectively experience hair regrowth.

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  • Warnings:

    For external use only. For use by men only.

    Flammable: Keep away from fire or flame

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  • Ask a doctor before use if you have: heart disease
  • When using this product

    • do not apply on other parts of the body
    • avoid contact with the eyes. In case of accidental contact, rinse eyes with large amounts of cool tap water.
    • some people have experienced changes in hair color and/or texture
      • it takes time to regrow hair. Results may occur at 2 months with twice a day usage. For some men, you may need to use this product for at least 4 months before you see results.
    • the amount of hair regrowth is different for each person. This product will not work for all men.
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  • Stop use and ask a doctor if

    • chest pain, rapid heartbeat, faintness, or dizziness occurs
    • sudden, unexplained weight gain occurs
    • your hands or feet swell
    • scalp irritation or redness occurs
    • unwanted facial hair growth occurs
    • you do not see hair regrowth in 4 months
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  • May be harmful if used when pregnant or breast-feeding.
  • Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
  • Directions:

    • apply one mL with dropper 2 times a day directly onto the scalp in the hair loss area
    • using more or more often will not improve results
    • continued use is necessary to increase and keep your hair regrowth, or hair loss will begin again
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  • Inactive ingredients:

    Ricinus communis, Citrus bergamia, amino acids, mint extract, propylene glycol.

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  • Questions?

    • call toll-free 800-764-2463 or 215-273-8755 (collect)
    • visit www.rogaine.com
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  • Barbiux Tonic With Minoxidil 60 ml Incredible Products minoxidil
  • INGREDIENTS AND APPEARANCE
    BARBIUX BALSAMIC TONIC 5% 
    minoxidil solution
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:71761-260
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    MINOXIDIL (UNII: 5965120SH1) (MINOXIDIL - UNII:5965120SH1) MINOXIDIL 0.05 mg  in 1 mL
    Inactive Ingredients
    Ingredient Name Strength
    RICINUS COMMUNIS SEED (UNII: 7EK4SFN1TX)  
    BERGAMOT ORANGE (UNII: IET5D90X0D)  
    AMINO ACIDS (UNII: 0O72R8RF8A)  
    PEPPERMINT (UNII: V95R5KMY2B)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:71761-260-60 60 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 07/03/2019
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    ANDA ANDA076239 07/03/2019
    Labeler - Incredible Products, S.A. de C.V. (815397500)
    Registrant - Incredible Products, S.A. de C.V. (815397500)
    Establishment
    Name Address ID/FEI Business Operations
    Incredible Products, S.A. de C.V. 815397500 manufacture(71761-260) , pack(71761-260) , label(71761-260)
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