Label: VITILIGO ORGANICS- cullen corylifolium whole plant, berberis vulgaris root bark, nigella sativa seed, organic coconut oil ointment

  • NDC Code(s): 70957-0020-1, 70957-0020-2
  • Packager: Organic Care Australia Pty 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 December 11, 2023

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  • Actives 

    Each 1g contains:

    Cullen corylifolium whole plant...83mg

    Berberis vulgaris root bark...83mg

    Nigella sativa seed...83mg

  • Purpose

    For repigmentation of skin

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children

  • Warnings

    • For external use only
    • If symptoms persist consult your healthcare practitioner
    • Store below 86 oF

  • Directions

    Clean the affected area Apply generously and massage into the skin every day and night before bed Leave it on without rinsing for 8-10 hours Lotion solidifies in cold weather.

    Immerse bottle in a warm bowl of water until liquefied Shake well before use

  • Usage

    Homeopathic remedy that helps in pigmentation of skin affected by vitiligo.

  • Inactives

    Coconut Oil

  • PRINCIPAL DISPLAY PANEL

    voau_250ml_2016_v1voau_125ml_2016_v1

  • INGREDIENTS AND APPEARANCE
    VITILIGO ORGANICS 
    cullen corylifolium whole plant, berberis vulgaris root bark, nigella sativa seed, organic coconut oil ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70957-0020
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BERBERIS VULGARIS ROOT BARK (UNII: 1TH8Q20J0U) (BERBERIS VULGARIS ROOT BARK - UNII:1TH8Q20J0U) BERBERIS VULGARIS ROOT BARK83 mg  in 125 mL
    CULLEN CORYLIFOLIUM WHOLE (UNII: M8Z0AK5HFO) (CULLEN CORYLIFOLIUM WHOLE - UNII:M8Z0AK5HFO) CULLEN CORYLIFOLIUM WHOLE83 mg  in 125 mL
    NIGELLA SATIVA SEED (UNII: 4LVZ0Z0ITT) (NIGELLA SATIVA SEED - UNII:4LVZ0Z0ITT) NIGELLA SATIVA SEED83 mg  in 125 mL
    Inactive Ingredients
    Ingredient NameStrength
    COCONUT OIL (UNII: Q9L0O73W7L) 752 mg  in 125 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70957-0020-1125 mL in 1 BOTTLE; Type 0: Not a Combination Product09/07/2016
    2NDC:70957-0020-2250 mL in 1 BOTTLE; Type 0: Not a Combination Product09/07/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic09/07/2016
    Labeler - Organic Care Australia Pty LTD (757612684)
    Registrant - Organic Care Australia Pty LTD (757612684)
    Establishment
    NameAddressID/FEIBusiness Operations
    FERNGROVE PHARMACEUTICALS AUSTRALIA PTY LTD746201743manufacture(70957-0020)
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