NUTRASTIM HAIR REGROWTH TREATMENT UNSCENTED FOR MEN (MINOXIDIL) SOLUTION [PULSADERM LLC]

NUTRASTIM HAIR REGROWTH TREATMENT UNSCENTED FOR MEN (MINOXIDIL) SOLUTION [PULSADERM LLC]
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NDC 71177-005-01, 71177-005-02
Set ID 48850f93-6fc8-7008-e054-00144ff8d46c
Category HUMAN OTC DRUG LABEL
Packager Pulsaderm Llc
Generic Name
Product Class Arteriolar Vasodilator
Product Number
Application Number ANDA075598
  • Nutrastim Hair Regrowth Treatment Topical Solution USP, 5% Unscented Topical Solution For Men Drug Facts Panel

  • Active ingredient:

    Minoxidil 5% w/v

  • Purpose

    Hair regrowth treatment for men.

  • 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 DOCTOR

    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 with each person. This product will not work for all men.
  • Stop use and call your 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.
    • You do not see hair regrowth in 4 months.
  • PREGNANCY OR BREAST FEEDING

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

  • 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).

  • Directions

    • Apply 1 ml, 2 times daily directly with the dropper 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

    • Before use see hair loss pictures on side of this box.
    • Keep the box, it contains important information.
    • Hair regrowth has not been shown to last longer than 48 weeks in large clinical trials with the 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 20° to 25° C (68° to 77° F).

    Keep tightly closed.

  • Inactive ingredients:

    Alcohol, propylene glycol, purified water

  • Questions?

    Call us at 1-844-892-8578

    Visit nutrastimhair.com

    for more information about hair thinning, visit

    nutrastimhair.com/men-education/

  • Nutrastim Hair Regrowth Treatment Topical Solution USP, 5% Unscented Topical Solution For Men Two Month Supply

    NutrastimMFrontBox.jpg NutrastimMFrontBox.jpgNutrastimMBackBox.jpg NutrastimMBackBox.jpg

  • INGREDIENTS AND APPEARANCE
    NUTRASTIM  HAIR REGROWTH TREATMENT UNSCENTED FOR MEN
    minoxidil solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71177-005
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MINOXIDIL (UNII: 5965120SH1) (MINOXIDIL - UNII:5965120SH1) MINOXIDIL50 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALCOHOL (UNII: 3K9958V90M)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71177-005-022 in 1 CARTON02/14/2017
    1NDC:71177-005-0160 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07559802/14/2017
    Labeler - Pulsaderm Llc (080429881)
    Establishment
    NameAddressID/FEIBusiness Operations
    Chemolee Lab Corporation809982754manufacture(71177-005)

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