Label: MENS MINOXIDIL HAIR REGROWTH- minoxidil kit

  • NDC Code(s): 51326-160-16, 51326-165-01
  • Packager: Topiderm, Inc
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated June 20, 2023

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient

    Minoxidil 5% w/v

  • Purpose

    Hair regrowth treatment for men

  • Use

    to regrow hair on the scalp (vertex only, see picture 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. 5% minoxidil topical solution 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, 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.

  • Directions

    • apply one mL with dropper 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 opposite side
    • before use, read all information on carton and enclosed leaflet
    • keep the insert. It contains important information.
    • hair regrowth has not been shown to last longer than 48 weeks in large clinical trials with continuous treatment with 5% minoxidil topical solution for men
    • in clinical studies of mostly white men aged 18-49 years with moderate degrees of hair loss, 5% minoxidil topical solution for men provided more hair regrowth than 2% minoxidil topical solution
    • store at controlled room temperature 20º to 25ºC (68º to 77ºF).
  • Inactive ingredients

    Alcohol, Propylene Glycol, Purified Water

  • PRINCIPAL DISPLAY PANEL - Kit Carton

    MINOXIDIL
    HAIR REGROWTH SYSTEM

    CLINICALLY PROVEN TO HELP REGROW HAIR

    KIT CONTENTS: STRENGTHENING SHAMPOO, REJUVENATING CONDITIONER,
    MINOXIDIL TOPICAL SOLUTION USP (2 MONTH SUPPLY)

    PRINCIPAL DISPLAY PANEL - Kit Carton
  • PRINCIPAL DISPLAY PANEL - 2-60 ml Bottle Dropcard

    MEN'S
    MINOXIDIL
    HAIR REGROWTH SYSTEM

    5% MINOXODIL TOPICAL SOLUTION, USP

    Reactivates hair follicles to
    stimulate regrowth

    Clinically proven to help regrow hair

    Topical Solution

    Unscented

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

    If men have more hair loss or hair loss in a place
    different than shown above, Minoxidil Topical
    Solution 5% may not work.

    Two month supply
    Two 60 ml (2 fl oz) bottles

    PRINCIPAL DISPLAY PANEL - 2-60 ml Bottle Dropcard
  • PRINCIPAL DISPLAY PANEL - 200 ml Bottle Label-Shampoo

    COMPLIMENTS OF
    TOPIX
    PHARMACEUTICALS, INC

    Strengthening
    Basil Root
    Shampoo

    HAIR GROWTH SYSTEM

    Clean | Volumize | Strengthen

    Net 6.7 fl. oz. (200 ml)

    Available
    Custom Branded
    800.445.2595
    c.service@topixpharm.com

    PRINCIPAL DISPLAY PANEL - 200 ml Bottle Label-Shampoo
  • PRINCIPAL DISPLAY PANEL - 200 ml Bottle Label-Conditioner

    COMPLIMENTS OF
    TOPIX
    PHARMACEUTICALS, INC

    Rejuvenating
    Basil Root
    Conditioner

    HAIR GROWTH SYSTEM

    Condition | Volumize | Rejuvenate

    Net 6.7 fl. oz. (200 ml)

    Available
    Custom Branded
    800.445.2595
    c.service@topixpharm.com

    PRINCIPAL DISPLAY PANEL - 200 ml Bottle Label-Conditioner
  • INGREDIENTS AND APPEARANCE
    MENS MINOXIDIL HAIR REGROWTH 
    minoxidil kit
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51326-165
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51326-165-011 in 1 CARTON06/16/2023
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 12 BOTTLE 120 mL
    Part 21 BOTTLE 200 mL
    Part 31 BOTTLE 200 mL
    Part 1 of 3
    MENS MINOXIDIL   HAIR GROWTH SYSTEM
    minoxidil solution
    Product Information
    Item Code (Source)NDC:51326-160
    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:51326-160-1660 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07623903/23/2021
    Part 2 of 3
    STRENGTHENING BASIL ROOT 
    shampoos (non-coloring) shampoo
    Product Information
    Route of AdministrationTOPICAL
    Other Ingredients
    Ingredient KindIngredient NameQuantity
    INGRWATER (UNII: 059QF0KO0R)  
    INGRCOCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    INGRSODIUM LAUROYL SARCOSINATE (UNII: 632GS99618)  
    INGRSODIUM COCOYL ISETHIONATE (UNII: 518XTE8493)  
    INGRSODIUM LAURYL SULFOACETATE (UNII: D0Y70F2B9J)  
    INGRGLYCERIN (UNII: PDC6A3C0OX)  
    INGRPANTHENOL (UNII: WV9CM0O67Z)  
    INGRPROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    INGR.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    INGRDIOSCOREA VILLOSA TUBER (UNII: IWY3IWX2G8)  
    INGRTRIFOLIUM PRATENSE FLOWER (UNII: 4JS0838828)  
    INGRPOTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    INGRSPHINGANINE (UNII: YT0ZSD64HM)  
    INGRCITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    INGRESCULIN (UNII: 1Y1L18LQAF)  
    INGRGLYCOL DISTEARATE (UNII: 13W7MDN21W)  
    INGRPOLIDOCANOL (UNII: 0AWH8BFG9A)  
    INGRC11-15 ALKETH-7 (UNII: 261HPE0IS3)  
    INGRDIPROPYLENE GLYCOL (UNII: E107L85C40)  
    INGRDECYL GLUCOSIDE (UNII: Z17H97EA6Y)  
    INGRPOLYQUATERNIUM-10 (400 MPA.S AT 2%) (UNII: HB1401PQFS)  
    INGRPOLYQUATERNIUM-7 (70/30 ACRYLAMIDE/DADMAC; 1600000 MW) (UNII: 0L414VCS5Y)  
    INGRPEG-55 PROPYLENE GLYCOL OLEATE (UNII: 7RDE7PJS40)  
    INGRMENTHONE 1,2-GLYCEROL KETAL, (+/-)- (UNII: 7QQ1EE6RCP)  
    INGRTRIDECETH-12 (UNII: YFY3KG5Y7O)  
    INGRACETYL TETRAPEPTIDE-3 (UNII: D1HW9N9QBX)  
    INGRBUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    INGRBENZYL ALCOHOL (UNII: LKG8494WBH)  
    INGRCARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    INGRSODIUM BENZOATE (UNII: OJ245FE5EU)  
    INGRSODIUM HYDROXIDE (UNII: 55X04QC32I)  
    INGRBUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    INGREDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
    INGRPHENOXYETHANOL (UNII: HIE492ZZ3T)  
    INGRBASIL (UNII: 2U0KZP0FDW)  
    INGRLOQUAT (UNII: DM9CY56A36)  
    INGRPEA (UNII: W4X7H8GYFM)  
    INGRAMODIMETHICONE (1300 CST) (UNII: 3V7U636DWN)  
    INGRDEXTRAN 110 (UNII: 05Q25F6XJ3)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1200 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    COSMETIC03/23/2021
    Part 3 of 3
    REJUVENATING BASIL ROOT CONDITIONER 
    shampoos (non-coloring) shampoo
    Product Information
    Route of AdministrationTOPICAL
    Other Ingredients
    Ingredient KindIngredient NameQuantity
    INGRWATER (UNII: 059QF0KO0R)  
    INGRSTEARALKONIUM CHLORIDE (UNII: 0OUO26BB88)  
    INGRCETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    INGRSTEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
    INGRTRIFOLIUM PRATENSE FLOWER (UNII: 4JS0838828)  
    INGRPOTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    INGRSPHINGANINE (UNII: YT0ZSD64HM)  
    INGRCITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    INGRRESVERATROL (UNII: Q369O8926L)  
    INGRSILIBININ (UNII: 4RKY41TBTF)  
    INGRCAFFEINE (UNII: 3G6A5W338E)  
    INGRESCULIN (UNII: 1Y1L18LQAF)  
    INGRPOLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)  
    INGRCYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    INGRACETYL TETRAPEPTIDE-3 (UNII: D1HW9N9QBX)  
    INGRBUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    INGRZINC PIDOLATE (UNII: C32PQ86DH4)  
    INGRCOPPER PIDOLATE (UNII: 497G7G1SL1)  
    INGRSODIUM CHLORIDE (UNII: 451W47IQ8X)  
    INGRSODIUM BENZOATE (UNII: OJ245FE5EU)  
    INGREDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
    INGRPHENOXYETHANOL (UNII: HIE492ZZ3T)  
    INGRBASIL (UNII: 2U0KZP0FDW)  
    INGRLOQUAT (UNII: DM9CY56A36)  
    INGRPEA (UNII: W4X7H8GYFM)  
    INGRTEA LEAF OIL (UNII: VC855RRT77)  
    INGRDEXTRAN 110 (UNII: 05Q25F6XJ3)  
    INGRLECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1200 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    COSMETIC03/23/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07623906/16/2023
    Labeler - Topiderm, Inc (049121643)
    Registrant - Topiderm, Inc. (049121643)
    Establishment
    NameAddressID/FEIBusiness Operations
    Topix Pharmaceuticals, Inc.117745066PACK(51326-165)
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