Label: CERAFILL RETALIATE EXTRA STRENGTH FOR MEN- minoxidil solution

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

Drug Label Information

Updated December 19, 2017

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

  • Drug Facts
  • Active ingredient

    Minoxidil, USP 5% w/v

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  • Purpose

    Hair regrowth treatment for men

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  • 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

    Do not use if

    • you are a woman
    • your amount of hair loss is different than that shown on the side of this carton or your hair loss is on the front of the scalp. Minoxidil topical solution 5% 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 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. 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.

    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.

    Keep out of reach of children.

    If swallowed, get medical help or contact a Poison Control Center right away.

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  • Directions

    • apply one mL 2 times a day directly onto the scalp in the area of hair thinning or hair loss area
    • spread the liquid evenly over the hair loss area. If you use your fingers, wash hands with soap and warm water immediately.
    • 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 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 trials with continuous treatment with minoxidil topical solution 5% for men
    • in clinical studies with mostly white men aged 18-49 years with moderate degrees of hair loss, minoxidil topical solution 5% for men provided more hair regrowth than minoxidil topical solution 2%
    • store at controlled room temperature 20° to 25°C (68° to 77°F). Keep tightly closed.
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  • Inactive ingredients

    alcohol (30% v/v), propylene glycol (50% v/v), purified water

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  • Questions?

    1-800-432-8534 between 9 am and 4 pm EST, Monday–Friday.

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  • Principal Display Panel

    cerafill
    retaliate
    minoxidil topical solution, USP 5%
    hair regrowth treatment
    EXTRA STRENGTH FOR MEN
    (Read enclosed leaflet before use)

    minoxidil topical solution, USP 5%
    hair regrowth
    treatment
    extra strength
    for men
    revitalizes hair follicles
    CLINICALLY PROVEN TO HELP REGROW HAIR

    NOT FOR USE BY WOMEN

    1 Month Supply

    1-60 mL (2 fl oz) Bottle

    REDKEN

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  • INGREDIENTS AND APPEARANCE
    CERAFILL RETALIATE  EXTRA STRENGTH FOR MEN
    minoxidil solution
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:49967-760
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    MINOXIDIL (UNII: 5965120SH1) (MINOXIDIL - UNII:5965120SH1) MINOXIDIL 50 mg  in 1 mL
    Inactive Ingredients
    Ingredient Name Strength
    ALCOHOL (UNII: 3K9958V90M)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:49967-760-01 2 in 1 CARTON 04/28/2014 04/30/2018
    1 60 mL in 1 BOTTLE; Type 1: Convenience Kit of Co-Package
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    ANDA ANDA075518 04/28/2014 04/30/2018
    Labeler - L'oreal Usa, Inc. (002136794)
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