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
- Purpose
- KEEP OUT OF REACH OF CHILDREN
- Warnings
- Directions
- Usage
- Inactives
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
VITILIGO ORGANICS
cullen corylifolium whole plant, berberis vulgaris root bark, nigella sativa seed, organic coconut oil ointmentProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:70957-0020 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BERBERIS VULGARIS ROOT BARK (UNII: 1TH8Q20J0U) (BERBERIS VULGARIS ROOT BARK - UNII:1TH8Q20J0U) BERBERIS VULGARIS ROOT BARK 83 mg in 125 mL CULLEN CORYLIFOLIUM WHOLE (UNII: M8Z0AK5HFO) (CULLEN CORYLIFOLIUM WHOLE - UNII:M8Z0AK5HFO) CULLEN CORYLIFOLIUM WHOLE 83 mg in 125 mL NIGELLA SATIVA SEED (UNII: 4LVZ0Z0ITT) (NIGELLA SATIVA SEED - UNII:4LVZ0Z0ITT) NIGELLA SATIVA SEED 83 mg in 125 mL Inactive Ingredients Ingredient Name Strength COCONUT OIL (UNII: Q9L0O73W7L) 752 mg in 125 mL Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70957-0020-1 125 mL in 1 BOTTLE; Type 0: Not a Combination Product 09/07/2016 2 NDC:70957-0020-2 250 mL in 1 BOTTLE; Type 0: Not a Combination Product 09/07/2016 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 09/07/2016 Labeler - Organic Care Australia Pty LTD (757612684) Registrant - Organic Care Australia Pty LTD (757612684) Establishment Name Address ID/FEI Business Operations FERNGROVE PHARMACEUTICALS AUSTRALIA PTY LTD 746201743 manufacture(70957-0020)