Label: REGENIVADE HAIR GROWTH FOAM (regenivade hair growth- serum foam liquid

  • NDC Code(s): 81653-008-01, 81653-008-02, 81653-008-03
  • Packager: Guangzhou Jianyuan Biological Technology.Co.,Ltd
  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated November 28, 2023

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

  • Active Ingredient

    Minoxidil 5% w/ v.

  • Purpose

    Hair regrowth treatment for men and women

  • Use

    To regrow hair

  • Warnings

    For external use only.
    Flammable: Keep away from fire or flame

  • Do not use

    Do not use if :

    *You are a pregnant 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 foam is not intended for frontal baldness or
    receding hairline.
    .You suffer from metal allergies
    .You have no family history of hair loss.
    .You 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.
    *You scalp is red, inflamed, infected, irritated, or painful.
    ·You use other medicines on the scalp.

  • When Using

    ●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 withtwice a day usage. For some people, 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. Thisproduct will not work for all people.

  • Stop Use

    .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.

  • Ask Doctor

    If have Allergy, plz check with doctor

  • Keep Oot Of Reach Of Children

    Yes, Keep Oot Of Reach Of Children

  • Directions

    ●Men: Apply half a capful 2 times a day to the hair loss area.
    ●Women: Apply half a capful 1 time a day to the hair loss area.
    ●Massage to area with fingers, then wash hands well.
    ●Using more and more often will not improve results.

  • Other information

    .Hair growth has been shown in a clinical study of men (mostly
    white) aged 18-49 years who used it for 4 months.
    ·Store at controlled room temperature 20°to 25°C (68° to 77°F)
    contents under pressure. Do not puncture or incinerate container.
    Do not expose to heat or store at temperatures above 120°F (49℃).

  • Inactive ingredients

    Aqua,hyaluronic acid, Cocamidopropyl betaine,keratin amino acids,tocopherol (vitamin E), glycerol, xanthan gum, Glyoxyloyl , allantoin, aloe barbadensis leaf extract, propylene glycol, vitas vinifera seed extract, polygonum cuspidatum extract, ethylhexlglycerin, biotin, argania spinosa kernel oil,simmondsia chinesis (jojoba) seed oil, castor oil, saw palmetto, peppermint oil,rosemary oil, pumpkin seed oil, caffeine, stinging nettle, niancinimide, Green tea.

  • Questions

    Visit www.regenivade.com
    (732) 893-0603

  • PRINCIPAL DISPLAY PANEL

    010203

  • INGREDIENTS AND APPEARANCE
    REGENIVADE HAIR GROWTH FOAM 
    regenivade hair growth (serum) foam liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:81653-008
    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
    VITIS VINIFERA POLLEN (UNII: 83OVS854BE)  
    WATER (UNII: 059QF0KO0R)  
    SAW PALMETTO (UNII: J7WWH9M8QS)  
    ROSEMARY OIL (UNII: 8LGU7VM393)  
    URTICA DIOICA (UNII: 710FLW4U46)  
    POLYGONUM CUSPIDATUM LEAF (UNII: 2540B7G25G)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    BIOTIN (UNII: 6SO6U10H04)  
    JOJOBA OIL (UNII: 724GKU717M)  
    PEPPERMINT OIL (UNII: AV092KU4JH)  
    N-ETHYLHEXEDRONE (UNII: TAX3KSX6GY)  
    HYALURONIC ACID (UNII: S270N0TRQY)  
    GLYOXYLOYL CARBOCYSTEINE (UNII: 3K6008UJ5J)  
    ALLANTOIN (UNII: 344S277G0Z)  
    PUMPKIN SEED OIL (UNII: 6E5QR5USSP)  
    CAFFEINE (UNII: 3G6A5W338E)  
    NIACIN (UNII: 2679MF687A)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    ARGAN OIL (UNII: 4V59G5UW9X)  
    CASTOR OIL (UNII: D5340Y2I9G)  
    AMINO ACIDS, HAIR KERATIN (UNII: G46579QK1M)  
    .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:81653-008-0160 mL in 1 BOTTLE; Type 0: Not a Combination Product11/12/2023
    2NDC:81653-008-02180 mL in 1 BOTTLE; Type 1: Convenience Kit of Co-Package11/12/2023
    3NDC:81653-008-03360 mL in 1 BOTTLE; Type 1: Convenience Kit of Co-Package11/12/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07535711/12/2023
    Labeler - Guangzhou Jianyuan Biological Technology.Co.,Ltd (548120189)
    Establishment
    NameAddressID/FEIBusiness Operations
    Guangzhou Jianyuan Biological Technology.Co.,Ltd548120189manufacture(81653-008)