RE-GRO (MINOXIDIL) SOLUTION [EMPRESS HAIR PRODUCTS, LTD.]

RE-GRO (MINOXIDIL) SOLUTION [EMPRESS HAIR PRODUCTS, LTD.]
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NDC 60900-555-10, 60900-555-20, 60900-555-30
Set ID f7d77d71-566f-4b9f-90a7-7a4ae82f567f
Category HUMAN OTC DRUG LABEL
Packager Empress Hair Products, Ltd.
Generic Name
Product Class Arteriolar Vasodilator
Product Number
Application Number ANDA074588
  • Drug Facts

  • Active ingredient

    Minoxidil, USP 2% w/v

  • Purpose

    Hair regrowth treatment

  • INDICATIONS & USAGE

    Use to regrow hair on the scalp

  • Warnings

    For external use only
    Flammable: Keep away from fire or flame

  • DO NOT USE

    Do not use if

    • your degree of hair loss is more than that shown on the side of this carton, because this propuct 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 on babies and children.
    • your scalp is red, inflamed, infected, irritated, or painful
    • you use other medicines on the scalp
  • ASK DOCTOR

    Ask a doctor before use if you have heart disease

  • WHEN USING

    When using this product

    • do not apply on other parts of the body
    • avoid contact with the eyes. In case of accidental contact, rinse 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

    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.

    Directions

    • part your hair and apply with dropper one mL 2 times a day directly onto the scalp in the area of hair thinning/loss
    • 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
  • Other information

    • see hair loss pictures on side of this carton
    • before use, read all information on carton and enclosed leaflet
    • keep this carton. It contains important information.
    • in clinical studies of mostly white women aged 18-45 years with mild to moderate degrees of hair loss, the following response to minoxidil topical solution 2% was reported: 19% of women reported moderate hair regrowth after using minoxidil topical solution 2% for 8 months (19% had moderate regrowth; 40% had minimal regrowth). This compares with 7% of women reporting moderate hair regrowth after using the placebo, the liquid without minoxidil in it, for 8 months (7% had moderate regrowth; 33% had minimal regrowth).
    • store at controlled room temperature 20° to 25°C (68° to 77°F). Keep tightly closed.
  • INACTIVE INGREDIENT

    Inactive ingredients alcohol (60% v/v), propylene glycol, purified water

  • QUESTIONS

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

  • ———Package Label.Principal Display Panel———

    NDC 60900-555-30

    Compare to the active ingredient
    in Women's Rogaine®*

    EMPRESS®

    Re-Gro™ Hair Products for Women of Color

    Hair Regrowth
    Treatment

    Minoxidil Topical
    Solution,
    USP 2%
    FOR WOMEN

    Unscented

    Clinically Proven to
    Help Regrow Hair

    Revitalized Hair Follicles

    Three Month Supply
    3-60 mL (2 fl oz) Bottles

    product label
  • INGREDIENTS AND APPEARANCE
    RE-GRO 
    minoxidil solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:60900-555
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MINOXIDIL (UNII: 5965120SH1) (MINOXIDIL - UNII:5965120SH1) MINOXIDIL2 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALCOHOL (UNII: 3K9958V90M)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:60900-555-101 in 1 CARTON
    160 mL in 1 BOTTLE
    2NDC:60900-555-202 in 1 CARTON
    260 mL in 1 BOTTLE
    3NDC:60900-555-303 in 1 CARTON
    360 mL in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07458804/01/2014
    Labeler - Empress Hair Products, Ltd. (175791966)
    Establishment
    NameAddressID/FEIBusiness Operations
    Contract Pharmaceuticals Limited Canada248761249manufacture(60900-555)

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