Label: GIILAVY HAIR REGROWTH TREATMENT- hair regrowth treatment liquid

  • NDC Code(s): 84249-002-01, 84249-002-02
  • Packager: Ningbo Junyi Trading Co., Ltd
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated April 25, 2024

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  • Active Ingredient

    Minoxidil 5% w/w

  • Purpose

    Hair or beard regrowth treatment

  • Use

  • Warnings

    For external use only

  • Do not use

    you do not know the reason for your hair or beard loss
    you are under 18 years of age.Do not use on babies and children
    your under hair or beard skin is red,inflamed,infected,imitated or painful
    you use other medicines on your under hair or beard skin

  • When Using

    do not apply on other parts of the body, except the hair or beard
    avoid contact with the eyes. In case of accidental contact, rinse eyes with large amount of cool tap water
    it takes time to regrow hair. Results may occur at 4 months with continuous usage
    the amount of hair or beard regrowth is different for each person. This product will not work for all men

  • Stop Use

    chest pain, rapid heartbeat, faintness, or dizziness occurs
    sudden,unexplained weight gain occurs
    your hands or feet swell
    skin imitation or redness occurs
    you do not see hair or beard regrowth in 4 months

  • Ask Doctor

    chest pain, rapid heartbeat, faintness, or dizziness occurs
    sudden,unexplained weight gain occurs
    your hands or feet swell
    skin imitation or redness occurs
    you do not see hair or beard regrowth in 4 months

  • Keep Oot Of Reach Of Children

    If swallowed,get medical help or contact a Poison Control Center right away

  • Directions

    apply 1ml(5 sprays) twice a day directly to the roots of the hair or beard loss area

  • Other information

    store at 20-25℃(68-77°F)

  • Inactive ingredients

    Aloe Vera Extract,Biotin, Castor Oil,Deionized Water,Ethanol, Glycerin, Niacinamide, Panthenol,,Rosemary Oil.

  • PRINCIPAL DISPLAY PANEL

    12

  • INGREDIENTS AND APPEARANCE
    GIILAVY HAIR REGROWTH TREATMENT 
    hair regrowth treatment liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:84249-002
    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
    CASTOR OIL (UNII: D5340Y2I9G)  
    ALCOHOL (UNII: 3K9958V90M)  
    BIOTIN (UNII: 6SO6U10H04)  
    NIACINAMIDE (UNII: 25X51I8RD4)  
    WATER (UNII: 059QF0KO0R)  
    ROSEMARY OIL (UNII: 8LGU7VM393)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PANTHENOL (UNII: WV9CM0O67Z)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:84249-002-0160 mL in 1 BOTTLE; Type 0: Not a Combination Product04/08/2024
    2NDC:84249-002-022 in 1 BOX04/08/2024
    260 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA20907404/08/2024
    Labeler - Ningbo Junyi Trading Co., Ltd (699426142)
    Establishment
    NameAddressID/FEIBusiness Operations
    Ningbo Junyi Trading Co., Ltd699426142manufacture(84249-002)
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