Label: AZELOMAX FORTE- minoxidil 5% solution/ drops

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

Drug Label Information

Updated July 10, 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

    Use to regrow hair on the top of the scalp (vertex only, see pictures on side of carton)

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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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  • DO NOT USE

    Do not use if:

    • You are a woman
    • Your amount of hair loss is different than shown on the side of this carton or hair loss is on the front of the scalp, 5% minoxidil topical solution is not intended for frontal baldness or receding hairline
    • You have no family history of hair loss
    • Your hair loss is sudden and/or patchy
    • You do not know the reason for your hair loss
    • You are under 18 years of age. Do not use on babies or children
    • Your scalp is red, inflamed, infected, irritated, or painful
    • You use other medicines on the scalp
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  • ASK DOCTOR

    Ask your doctor before use if you have heart disease.

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  • 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 expereinced 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

    • Stop use and ask a doctor if
    • Chest pain, rapid heart beat, faintness, or dissiness occurs
    • Sudden, unexplained weight gain occurs
    • Your hands of feet swell
    • Scalp irritation or redness occurs
    • You get unwanted facial hair growth
    • You do not see hair regrowth in 4 months
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  • 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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  • OTHER INFORMATION

    • See hair loss pictures on the side of this carton
    • Before use, read all information on carton and enclosed leaflet
    • Keep the carton. It contains important information
    • Hair regrowth has not been shown to last longer than 48 weeks in large clinical trialse with continuous treatment with 5% minoxidil topical solution for men
    • In clincial studies of mostly white men aged 18-49 years with moderate degrees of hair loss, 5% minoxidil topical solution for men provide more hair regrowth than 2% minoxidil topical solution
    • Store at controlled room temperature 20 o to 25 oC (68 o to 77 oF)
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  • INACTIVE INGREDIENT

    Alcohol, Propylene Glycol, Purified Water

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  • QUESTIONS

    Questions or comments? +7-499-753-024-34

    • Visit Website at www.simone.su

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  • 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.

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  • PREGNANCY OR BREAST FEEDING

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

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  • INGREDIENTS AND APPEARANCE
    AZELOMAX FORTE 
    minoxidil 5% solution/ drops
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:73237-002
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    MINOXIDIL (UNII: 5965120SH1) (MINOXIDIL - UNII:5965120SH1) MINOXIDIL 5 g  in 100 mL
    Inactive Ingredients
    Ingredient Name Strength
    WATER (UNII: 059QF0KO0R)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:73237-002-01 1 in 1 BOX 07/10/2019
    1 60 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    ANDA ANDA076239 07/10/2019
    Labeler - TRILOGIC LTD (682372062)
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