Label: DIZOP MINOXIDIL TOPICAL GEL- minoxidil 5% gel

  • NDC Code(s): 83766-101-01, 83766-101-02, 83766-101-03, 83766-101-04
  • Packager: Shenzhen Joyuflsh Technology Co.,Ltd.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated November 5, 2023

If you are a consumer or patient please visit this version.

  • SPL UNCLASSIFIED SECTION

    Dizop Minoxidil Topical Gel

  • ACTIVE INGREDIENT

    Minoxidil 5%

  • PURPOSE

    Reactivates Hair Follicles To Stimulate RegrowthEasy-To-Use Minoxidil Gel

    Minoxidil Topical Gel, 5% (For Men), is designed for men experiencing general hair
    thinning on the top of the scalp, as depicted.

  • INDICATIONS & USAGE

    Hair regrowth treatment for men.
    Use to Regrow Hair on the Top of the Scalp (See Pictures on the Side of this Carton).

  • WARNINGS

    For external use only

  • DO NOT USE

    Your degree of hair loss differs from that shown on the side of this carton because this product may not work for you.
    Your hair loss is sudden, patchy, or a combination of both.
    You are under 18 years of age. Please do not use it on babies or children.
    Your scalp is red, inflamed, infected, irritated, or painful.
    You use other medicines on the scalp.

  • WHEN USING

    Do not use more than directed.
    Avoid contact with the eyes, ears, and mouth. In the event of accidental contact withthe eyes, rinse the affected area with a generous amount of cool tap waterimmediately.
    lt takes time to regrow hair. Results may occur after two months of once-daily useFor some individuals, it may take at least four months before results becomenoticeable.
    The efficacy of this product in promoting hair regrowth can differ from person to person, and it may not work for every man.

  • STOP USE

    Stop use and ask a doctor if you experience chest pain, a rapid heartbeat,faintness, or dizziness, or if scalp irritation or redness occurs. These may be signs of a serious condition

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. lf swallowed, get medical help or contact a Poison Control Center immediately at 1-800-222-1222

  • DOSAGE & ADMINISTRATION

    Apply 1 ml onto the scalp, where hair loss occurs, once daily and massaging gently for absorption.

  • STORAGE AND HANDLING

    Store between 41 and 86℉ (5 and 30 ℃). Avoid freezing and exposure to excessive heat above 95℉ (35°C)

  • INACTIVE INGREDIENT

    STEARIC ACID
    OLEIC ACID
    POLYSORBATE 80
    SORBITAN MONOOLEATE
    CARBOMER HOMOPOLYMER
    GLYCERIN
    PURIFIED WATER

  • PRINCIPAL DISPLAY PANEL

    label1

  • INGREDIENTS AND APPEARANCE
    DIZOP MINOXIDIL TOPICAL GEL 
    minoxidil 5% gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:83766-101
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MINOXIDIL (UNII: 5965120SH1) (MINOXIDIL - UNII:5965120SH1) MINOXIDIL5 mg  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    SORBITAN MONOOLEATE (UNII: 06XEA2VD56)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    OLEIC ACID (UNII: 2UMI9U37CP)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:83766-101-021 in 1 CARTON10/26/2023
    1NDC:83766-101-01100 mL in 1 BOTTLE; Type 0: Not a Combination Product
    2NDC:83766-101-041 in 1 CARTON10/26/2023
    2NDC:83766-101-0350 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA20907410/26/2023
    Labeler - Shenzhen Joyuflsh Technology Co.,Ltd. (603012375)
    Registrant - Shenzhen Joyuflsh Technology Co.,Ltd. (603012375)
    Establishment
    NameAddressID/FEIBusiness Operations
    Shenzhen Joyuflsh Technology Co.,Ltd.603012375manufacture(83766-101)