QILIB HAIR REGROWTH TREATMENT FOR MEN (MINOXIDIL) SOLUTION [GALDERMA LABORATORIES, L.P.]

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QILIB HAIR REGROWTH TREATMENT FOR MEN (MINOXIDIL) SOLUTION [GALDERMA LABORATORIES, L.P.]
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NDC 0299-4805-00
Set ID 40fa2bc3-4267-4893-b780-8e7ca3a497a8
Category HUMAN OTC DRUG LABEL
Packager Galderma Laboratories, L.P.
Generic Name
Product Class Arteriolar Vasodilator
Product Number
Application Number NDA020834
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  • Active Ingredients

    Minoxidil 5% w/v

  • Purpose

    Hair regrowth treatment

  • Use

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

  • 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 hairloss

    • you are under 18 years of age. Do not use on babies and children

    • your scalp is red, inflamed, 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 wtih the eyes. In cases 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 wtih 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

    • side effects occur: You may report side effects to FDA at 1-800-FDA-1088 or to Galderma at 1-866-735-4137.

    • 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

    If pregnant or breast-feeding, ask a health professional before use.

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    • apply 1 mL with sprayer (6 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

  • 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%.

    • in clinical studies with mostly white men age 18-45 years with moderate degrees of hair loss, Minoxidil Topical Solution, 5% extra strength 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.

  • Inactive Ingredients:

    Alcohol 30% v/v, Propylene Glycol 50% v/v, Purified Water

  • Questions or comments?

    Call your health professional or Galderma at 1-866-735-4137

  • Package Label

                         Qilib for Men Carton

    GALDERMA

    qilib™

    Extra strength

    5% MINOXIDIL

    TOPICAL SOLUTION

    HAIR REGROWTH

    TREATMENT

    FOR MEN

    REACTIVATES HAIR FOLLICLES TO STIMULATE REGROWTH

    • Clinically proven to help regrow hair

    • Spray solution for easy application

    • Unscented

    Not for use by women

    EASY TO USE

    SPRAY BOTTLE

    1 month supply

    1 - 60mL (2 FL OZ) Bottle

    GALDERMA

    qilib™

    HAIR REGROWTH

    TREATMENT

    FOR MEN

    5% MINOXIDIL TOPICAL SOLUTION

    Revitalizes Hair Follicles

    (Read enclosed leaflet before use)

    Drug Facts

    This Package Contains:

    • One 60 mL (2 FL OZ) Bottle of Qilib Hair Regrowth Treatment For Women (one month supply).

    • This package also contains an educational booklet.

    Qilib Hair Regrowth Treatment For Men (Minoxidil Topical Solution 5%) For men who have a general thinning of hair on the top of the scalp (vertex only as shown below). Not intended for frontal baldness or a receding hairline. 5% Minoxidil Topical Solution has been shown to regrow hair in men with the following degrees of thinning hair or hair loss:

    If men have more hair loss or hair loss in a place different than shown above, Qilib Hair Regrowth Treatment For Men may not work.

    qilib™

    Actual Size of 60 mL (2 FL OZ)

    5% MINOXIDIL TOPICAL SOLUTION

    Distributed by:

    Galderma Laboratories, LP.

    Fort Worth, Texas 76177 USA

    All trademarks are the property of thier respective owners

    P52977-0

  • INGREDIENTS AND APPEARANCE
    QILIB HAIR REGROWTH TREATMENT FOR MEN 
    minoxidil solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0299-4805
    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
    ALCOHOL (UNII: 3K9958V90M)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0299-4805-001 in 1 CARTON12/01/201504/28/2017
    160 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA02083412/01/2015
    Labeler - Galderma Laboratories, L.P. (047350186)
    Establishment
    NameAddressID/FEIBusiness Operations
    EI Inc.105803274manufacture(0299-4805)
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