Label: REGROWZ HOMOTHETIC RESTORATION SERUM MEN/WOMEN- allium cepa tulsi tellicherry bark methi seeds and leaves syrup

  • NDC Code(s): 70878-002-01, 70878-002-02
  • Packager: Regrowz Ltd
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved homeopathic

DISCLAIMER: This homeopathic product has not been evaluated by the Food and Drug Administration for safety or efficacy. FDA is not aware of scientific evidence to support homeopathy as effective.

Drug Label Information

Updated June 26, 2018

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

  • PURPOSE


    Purpose
    Opens up the pores Promotes hair re-growth

  • ACTIVE INGREDIENT

    Active Ingredients


    Allium Cepa 1x
    Tulsi, Tellicherry Bark, Methi Seeds and Leaves 1x

  • INDICATIONS & USAGE

    Uses

    Promotes hair re-growth Prevents or reduces hair loss Thickens existing hair

  • WARNINGS

    Warnings -
    For external use only
    Do not use on broken skin
    if you have ever had an allergic reaction to this product or any of its ingredients

    Stop use and ask a doctor if too much skin irritation or sensitivity develops or increase

    When using this product
    Do not use in or near the eyes, mouth or sensitive areas
    Do not exceed the recommended dose, as this will not re-grow your hair any faster

  • DOSAGE & ADMINISTRATION

    Directions

    • Apply the Scalp Stimulant using the applicator on the scalp where there is hair loss.

    • Wait 30 minutes before applying the Restoration Serum. Pour a few drops of the solution in to the palm of your hand and then evenly apply the solution to the scalp where you have suffered hair loss. Massage the solution into your scalp for one minute.

    • Wait at least 30-60 minutes and then either wash the solution off using a mild shampoo or leave the solution on until the morning.

    It is advised to cover your pillow with a cloth or towel.

  • KEEP OUT OF REACH OF CHILDREN


    Keep out of reach of children.

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

  • INACTIVE INGREDIENT

    Inactive ingredients


    Aloe barbadensis leaf juice, Amber Bel (Roots & Leaves), Aqua, Ayurvedic Daswani Flowers, Benzoic Acid, Bisme, Camellia sinensis leaf extract, Cocos Nucifera Oil, Cumin, Dehydroacetic Acid, Emblica Officinalis Fruit, Ethylhexylglycerin, Glycerin, Gradugumo, Halad, Indian Almond, Jad Ka Patta, Kashmiri (Roots), Kusand Rote, Kusturi, Kyauni, Malabal (Nuts), Murraya Koenigii stem extract, Nilambase (Roots), Panchali, Phenoxyethanol, Pudari Ke Roots/Small Flowers, Purtumber, Ring Berry, Rose Flower (1 flower per litre), Sesamum Indicum Seed Oil, Small Lemon, Vanispati (Flower), Wada, White Onions.

  • OTHER SAFETY INFORMATION

    Other information


    Store at 20-25ºC (68-77ºF)
    If the Restoration Serum has solidified, then simply put the tube into a bowl of warm water until the Serum becomes liquid again.

  • PRINCIPAL DISPLAY PANEL

    label

  • INGREDIENTS AND APPEARANCE
    REGROWZ HOMOTHETIC RESTORATION SERUM  MEN/WOMEN
    allium cepa tulsi tellicherry bark methi seeds and leaves syrup
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70878-002
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALLIUM CEPA WHOLE (UNII: 8P2VLG2456) (ALLIUM CEPA WHOLE - UNII:8P2VLG2456) ALLIUM CEPA WHOLE0.1 [hp_X]  in 25 mL
    FENUGREEK LEAF (UNII: 487RI96K8Z) (FENUGREEK LEAF - UNII:487RI96K8Z) FENUGREEK LEAF0.1 [hp_X]  in 25 mL
    HOLY BASIL LEAF (UNII: SCJ765569P) (HOLY BASIL LEAF - UNII:SCJ765569P) HOLY BASIL LEAF0.1 [hp_X]  in 25 mL
    HOLARRHENA PUBESCENS BARK (UNII: 5R6HPB294Y) (HOLARRHENA PUBESCENS BARK - UNII:5R6HPB294Y) HOLARRHENA PUBESCENS BARK0.1 [hp_X]  in 25 mL
    Inactive Ingredients
    Ingredient NameStrength
    ROSA CANINA FRUIT (UNII: 3TNW8D08V3)  
    CAMELLIA SINENSIS SEED OIL (UNII: O5R6DK2M9K)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    PHYLLANTHUS EMBLICA FRUIT (UNII: YLX4CW2576)  
    TERMINALIA CATAPPA LEAF (UNII: 4XBZ9J585L)  
    CUMIN (UNII: AG9BNA51DQ)  
    SESAME OIL (UNII: QX10HYY4QV)  
    LEMON (UNII: 24RS0A988O)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    CRATAEGUS LAEVIGATA FLOWER (UNII: 85EAT04F4H)  
    ACORUS CALAMUS ROOT (UNII: XY1K7KIQ0F)  
    JUSTICIA ADHATODA FLOWER (UNII: 78H25E1Q8G)  
    PSIDIUM GUAJAVA WHOLE (UNII: 4J570BB45U)  
    POGOSTEMON CABLIN WHOLE (UNII: H6UKY25H2P)  
    LAWSONIA INERMIS WHOLE (UNII: W7M7338R56)  
    ECLIPTA PROSTRATA WHOLE (UNII: 8138AB7E8Y)  
    CUSCUTA REFLEXA (UNII: 7317415HFO)  
    AZADIRACHTA INDICA BARK (UNII: G580B439YI)  
    WHITE WAX (UNII: 7G1J5DA97F)  
    TINOSPORA CORDIFOLIA WHOLE (UNII: 14LQ3064QJ)  
    ABELMOSCHUS MOSCHATUS WHOLE (UNII: M7QAW6696G)  
    BERBERIS LYCIUM WHOLE (UNII: FX8735J5YL)  
    GLYCYRRHIZA GLABRA (UNII: 2788Z9758H)  
    TERMINALIA CHEBULA WHOLE (UNII: SH421PVG8O)  
    CULLEN CORYLIFOLIUM SEED (UNII: 86026EY9FM)  
    HIBISCUS ROSA-SINENSIS WHOLE (UNII: 9M4P5ZIR89)  
    MURRAYA KOENIGII WHOLE (UNII: 67UQM80W9W)  
    SAPINDUS MUKOROSSI WHOLE (UNII: 2701B2CTPH)  
    CHRYSOPOGON ZIZANIOIDES WHOLE (UNII: J2F8377BJJ)  
    WHEAT GERM (UNII: YR3G369F5A)  
    BACOPA MONNIERA LEAF (UNII: Y04287JMZN)  
    GRAPTOPHYLLUM PICTUM WHOLE (UNII: 98J9414TLW)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70878-002-0125 mL in 1 SYRINGE, GLASS; Type 0: Not a Combination Product04/13/2017
    2NDC:70878-002-0275 mL in 1 SYRINGE, GLASS; Type 0: Not a Combination Product04/13/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic04/13/2017
    Labeler - Regrowz Ltd (220678265)
    Establishment
    NameAddressID/FEIBusiness Operations
    Regrowz Ltd220678265manufacture(70878-002)