Label: OLISMO 5% MINOXIDIL HAIR GROWTH SERUM liquid

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated April 16, 2024

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

  • Active Ingredient

    Minoxidil 5% w/w

  • Purpose

    Hair regrowth treatment

  • Use

    to regrow hair on the scalp

  • Warnings

    For external use only.

  • Do not use

    ■no one in your family has hair loss, but if you have hair loss is sudden or patchy or both.
    ■you don't know why your hair is falling out.
    ■you are under 18 years of age. Do not use it on babies and children.
    ■the scalp becomes red, inflamed, infected, inflamed, and painful.
    ■you are using other medicines on your scalp.

  • Stop Use

    ■Chest pain, rapid heart rate, fainting, and dizziness may occur.
    ■Sudden, unexplained weight gain.
    ■Your hands or feet swell
    ■Inflammation and redness of the scalp occur
    ■Unwanted hair grows on your face. After 4 months, the hair will stop growing.

  • Ask Doctor

    ■Chest pain, rapid heart rate, fainting, and dizziness may occur.
    ■Sudden, unexplained weight gain.
    ■Your hands or feet swell
    ■Inflammation and redness of the scalp occur
    ■Unwanted hair grows on your face. After 4 months, the hair will stop growing.

  • Keep Oot Of Reach Of Children

    If swallowed, get medical help or contact a poison control center right away.

  • Directions

    ■ Apply 2-3 drops of serum directly to the treated area of the scalp.
    ■ After massaging the scalp with your fingertips, wash your hands thoroughly. Using more of the hair growth serum or using it more often does not improve the results.
    ■Continued use is required to increase and maintain hair regrowth.
    ■ Discontinuation may lead to hair loss.

  • Other information

    ■Read all information on pack before use.
    ■Save the box. Contains important information.
    ■Store at controlled room temperature 20-25°C (68-77°F).
    ■Content under pressure. Do not puncture or burn container. Do not expose to heat or store above 120°F (9°C).

  • Inactive ingredients

    Biotin, Water, Propylene aGlycol, Dimethyl Isosorbide, Acetic Acid, Panthenol, Niacinamide, Polysorbate 20, Sodium Lauroyl Sarcosinate, Aloe Barbadensis Flower Extract, PEG-50 Hydrogenated Castor Oil, Perfume, Hydrolyzed Collagen

  • PRINCIPAL DISPLAY PANEL

    01

  • INGREDIENTS AND APPEARANCE
    OLISMO 5% MINOXIDIL HAIR GROWTH SERUM 
    olismo 5% minoxidil hair growth serum liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:83462-021
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MINOXIDIL (UNII: 5965120SH1) (MINOXIDIL - UNII:5965120SH1) MINOXIDIL5 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    DIMETHYL ISOSORBIDE (UNII: SA6A6V432S)  
    PANTHENOL (UNII: WV9CM0O67Z)  
    POLYOXYL 50 HYDROGENATED CASTOR OIL (UNII: R07D3A9614)  
    NIACINAMIDE (UNII: 25X51I8RD4)  
    BIOTIN (UNII: 6SO6U10H04)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    ALOE VERA FLOWER (UNII: 575DY8C1ER)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    SODIUM LAUROYL SARCOSINATE (UNII: 632GS99618)  
    HYDROLYSED MARINE COLLAGEN (ENZYMATIC; 2000 MW) (UNII: 2WID9OCG7P)  
    WATER (UNII: 059QF0KO0R)  
    ACETIC ACID (UNII: Q40Q9N063P)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:83462-021-0130 mL in 1 BOTTLE; Type 0: Not a Combination Product11/02/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA20907411/02/2023
    Labeler - Eubizrival LLC (036572203)
    Establishment
    NameAddressID/FEIBusiness Operations
    Eubizrival LLC036572203label(83462-021) , manufacture(83462-021)