Label: NR-11- minoxidil sulfate, finasteride, alfatradiol liquid

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Export only

Drug Label Information

Updated June 21, 2017

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  • DOSAGE & ADMINISTRATION

    Twice per day, dispense six sprays and massage NR-11 evenly into the
    scalp. Do not rinse. For best results, wash hair daily with a high-quality
    shampoo. Consult a health-care professional to establish your optimal
    treatment regimen.

  • WARNINGS

    FOR EXTERNAL USE ONLY. AVOID CONTACT WITH EYES. NOT FOR WOMEN. DO NOT
    USE THIS PRODUCT IF YOU HAVE HEART DISEASE OR ARE TAKING BLOOD-PRESSURE-LOWERING
    MEDICATIONS. DISCONTINUE USE IMMEDIATELY AND SEE A PHYSICIAN IF YOU EXPERIENCE
    CHEST PAIN OR RAPID HEARTBEAT. DO NOT USE IF YOU ARE UNDER 18 YEARS OF AGE. KEEP
    OUT OF REACH OF CHILDREN.

  • INACTIVE INGREDIENT

    DEIONIZED WATER, PROPYLENE GLYCOL, ETHYL ALCOHOL, LACTIC ACID, PANTHENYL ETHYL
    ETHER, INOSITOL, ACETYL METHIONINE, MILK PROTEIN, SODIUM CITRATE, ACETYL CYSTEINE,
    LACTOSE, CITRIC ACID, PHOSPHOLIPIDS, RETINOL, GLYCERIN, POLYSORBATE 80, MYRISTOYL
    PENTAPEPTIDE-17, COPPER TRIPEPTIDE-1, PHENOXYETHANOL, CAPRYLYL GLYCOL

  • INDICATIONS & USAGE

    Indicated for male pattern balness; for hair-regrowth

  • PURPOSE

    for hair-regrowth

  • KEEP OUT OF REACH OF CHILDREN

    DO NOT USE IF YOU ARE UNDER 18 YEARS OF AGE. KEEP
    OUT OF REACH OF CHILDREN.

  • ACTIVE INGREDIENT

    Minoxidil sulfate ............12%

    Finasteride..................... 0.1%

    Alfatradiol....................... 0.05%

  • PRINCIPAL DISPLAY PANEL

    NR11 LabelNR11 Box

  • INGREDIENTS AND APPEARANCE
    NR-11 
    minoxidil sulfate, finasteride, alfatradiol liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69188-163
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALFATRADIOL (UNII: 3VQ38D63M7) (ALFATRADIOL - UNII:3VQ38D63M7) ALFATRADIOL0.05 g  in 100 g
    MINOXIDIL SULFATE ESTER (UNII: 2H6K6Y231J) (MINOXIDIL - UNII:5965120SH1) MINOXIDIL SULFATE ESTER12 g  in 100 g
    FINASTERIDE (UNII: 57GNO57U7G) (FINASTERIDE - UNII:57GNO57U7G) FINASTERIDE0.01 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    CASEIN (UNII: 48268V50D5)  
    LACTOSE (UNII: J2B2A4N98G)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
    INOSITOL (UNII: 4L6452S749)  
    ACETYLCYSTEINE (UNII: WYQ7N0BPYC)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    MYRISTOYL PENTAPEPTIDE-4 (UNII: PMA59A699X)  
    PREZATIDE COPPER (UNII: 6BJQ43T1I9)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    ALCOHOL (UNII: 3K9958V90M)  
    LACTIC ACID (UNII: 33X04XA5AT)  
    PANTHENYL ETHYL ETHER (UNII: F4WMF8NX3B)  
    N-ACETYLMETHIONINE (UNII: 9J12WX5B6A)  
    RETINOL (UNII: G2SH0XKK91)  
    Product Characteristics
    Coloryellow (Light yellow thin liquid) Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69188-163-6060 g in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product06/21/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    Export only06/21/2017
    Labeler - DS Healthcare Group Inc. (015504134)
    Registrant - DS Healthcare Group Inc. (015504134)
    Establishment
    NameAddressID/FEIBusiness Operations
    DS Healthcare Group Inc.015504134relabel(69188-163)
    Establishment
    NameAddressID/FEIBusiness Operations
    A.I.G. Technologies Inc.171837367manufacture(69188-163)
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