Label: MINOXIDIL 2%- minoxidil lotion
MINOXIDIL 5%- minoxidil lotion

  • NDC Code(s): 77229-050-01, 77229-050-13, 77229-050-16, 77229-099-01, view more
    77229-099-13, 77229-099-16
  • Packager: Centro Internacional de Cosmiatría, S.A.P.I. de C.V.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated February 7, 2024

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

  • WARNINGS

    Warnings

    For external use only

    Flammable: Keep away from fire or flame.

    Do not use if

    your degree of hair loss is different than that shown on the side of this carton, because this product may not work for you
    you have no family history of hair loss
    your hair loss is sudden and/or patchy
    your hair loss is associated with childbirth
    you do not know the reason for your hair loss
    you are under 18 years of age. Do not use it on babies and children.
    your scalp is red, inflamed, infected, irritated, or painful
    you use other medicines on the scalp

    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. You may need to use this product 2 times a day 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 everyone.

    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

    May be harmful if used when pregnant or breast-feeding.

  • DOSAGE & ADMINISTRATION

    DIRECTIONS

    Before each application, prime the sprayer by holding the bottle upright and pump the sprayer 5 times to ensure delivery of full spray. Do not inhale mist.
    Apply 1 mL with sprayer (8 sprays) 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.

  • INACTIVE INGREDIENT

    ALCOHOL 3K9958V90M 0.25 g IACT
    ANHYDROUS CITRIC ACID XF417D3PSL 0.0093 g IACT
    BUTYLATED HYDROXYTOLUENE 1P9D0Z171K 0.001 g IACT
    PROPYLENE GLYCOL 6DC9Q167V3 0.637 g IACT
    WATER 059QF0KO0R 0.0827 g IACT

  • INDICATIONS & USAGE

    Purpose

    Hair regrowth treatment.

    Use

    To regrow hair on the scalp.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away. (1-800-222-1222)

  • PURPOSE

    Hair regrowth treatment

  • PRINCIPAL DISPLAY PANEL

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  • INGREDIENTS AND APPEARANCE
    MINOXIDIL 2% 
    minoxidil lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:77229-050
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MINOXIDIL (UNII: 5965120SH1) (MINOXIDIL - UNII:5965120SH1) MINOXIDIL0.02 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    ALCOHOL (UNII: 3K9958V90M) 0.25 g  in 1 g
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) 0.0093 g  in 1 g
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) 0.001 g  in 1 g
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3) 0.637 g  in 1 g
    WATER (UNII: 059QF0KO0R) 0.0827 g  in 1 g
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:77229-050-011 g in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product02/08/2024
    2NDC:77229-050-133 g in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product02/08/2024
    3NDC:77229-050-166 g in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product02/08/2024
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM03202/07/2024
    MINOXIDIL 5% 
    minoxidil lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:77229-099
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MINOXIDIL (UNII: 5965120SH1) (MINOXIDIL - UNII:5965120SH1) MINOXIDIL0.02 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    ALCOHOL (UNII: 3K9958V90M) 0.25 g  in 1 g
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) 0.0093 g  in 1 g
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) 0.001 g  in 1 g
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3) 0.637 g  in 1 g
    WATER (UNII: 059QF0KO0R) 0.0827 g  in 1 g
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:77229-099-011 g in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product02/08/2024
    2NDC:77229-099-133 g in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product02/08/2024
    3NDC:77229-099-166 g in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product02/08/2024
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM03202/07/2024
    Labeler - Centro Internacional de Cosmiatría, S.A.P.I. de C.V. (814124954)
    Establishment
    NameAddressID/FEIBusiness Operations
    Centro Internacional de Cosmiatría, S.A.P.I. de C.V.814124954manufacture(77229-050, 77229-099)