NDC 70957-0020 Vitiligo Organics

Cullen Corylifolium Whole Plant, Berberis Vulgaris Root Bark, Nigella Sativa Seed, Organic Coconut Oil

NDC Product Code 70957-0020

NDC CODE: 70957-0020

Proprietary Name: Vitiligo Organics What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.

Non-Proprietary Name: Cullen Corylifolium Whole Plant, Berberis Vulgaris Root Bark, Nigella Sativa Seed, Organic Coconut Oil What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.

NDC Code Structure

NDC 70957-0020-1

Package Description: 125 mL in 1 BOTTLE

NDC 70957-0020-2

Package Description: 250 mL in 1 BOTTLE

NDC Product Information

Vitiligo Organics with NDC 70957-0020 is a a human over the counter drug product labeled by Organic Care Australia Pty Ltd. The generic name of Vitiligo Organics is cullen corylifolium whole plant, berberis vulgaris root bark, nigella sativa seed, organic coconut oil. The product's dosage form is ointment and is administered via topical form.

Labeler Name: Organic Care Australia Pty Ltd

Dosage Form: Ointment - A semisolid3 dosage form, usually containing <20% water and volatiles5 and >50% hydrocarbons, waxes, or polyols as the vehicle. This dosage form is generally for external application to the skin or mucous membranes.

Product Type: Human Otc Drug What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

Vitiligo Organics Active Ingredient(s)

What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.

  • BERBERIS VULGARIS ROOT BARK 83 mg/125mL
  • CULLEN CORYLIFOLIUM WHOLE 83 mg/125mL
  • NIGELLA SATIVA SEED 83 mg/125mL

Inactive Ingredient(s)

About the Inactive Ingredient(s)
The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

  • COCONUT OIL (UNII: Q9L0O73W7L)

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Topical - Administration to a particular spot on the outer surface of the body. The E2B term TRANSMAMMARY is a subset of the term TOPICAL.

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Organic Care Australia Pty Ltd
Labeler Code: 70957
Marketing Category: UNAPPROVED HOMEOPATHIC - What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Start Marketing Date: 09-07-2016 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2021 What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.

Exclude Flag: N What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA’s requests for correction to deficient or non-compliant submissions. Values = ‘Y’ or ‘N’.

* Please review the disclaimer below.

Vitiligo Organics Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

Actives

Each 1g contains:Cullen corylifolium whole plant...83mgBerberis vulgaris root bark...83mgNigella sativa seed...83mg

Purpose

For repigmentation of skin

Otc - 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

* Please review the disclaimer below.