Rosacea
Thuja Occidentalis Leafy Twig
Forces Of Nature
Human Otc Drug
NDC 51393-4006Rosacea also known as Thuja Occidentalis Leafy Twig is a human otc drug labeled by 'Forces Of Nature'. National Drug Code (NDC) number for Rosacea is 51393-4006. This drug is available in dosage form of Solution/ Drops. The names of the active, medicinal ingredients in Rosacea drug includes Thuja Occidentalis Leafy Twig - 8 [hp_X]/1000mL . The currest status of Rosacea drug is Active.
Drug Information:
| Drug NDC: | 51393-4006 |
| The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC. |
| Proprietary Name: | Rosacea |
| Also known as the trade name. It is the name of the product chosen by the labeler. |
| Product Type: | Human Otc Drug |
| Indicates the type of product, such as Human Prescription Drug or Human OTC Drug. This data element corresponds to the “Document Type” of the SPL submission for the listing. |
| Non Proprietary Name: | Thuja Occidentalis Leafy Twig |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Forces Of Nature |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Solution/ Drops |
| The translation of the DosageForm Code submitted by the firm. There is no standard, but values may include terms like `tablet` or `solution for injection`.The complete list of codes and translations can be found www.fda.gov/edrls under Structured Product Labeling Resources. |
| Status: | Active |
| FDA does not review and approve unfinished products. Therefore, all products in this file are considered unapproved. |
| Substance Name: | THUJA OCCIDENTALIS LEAFY TWIG - 8 [hp_X]/1000mL
|
| This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted. |
| Route Details: | TOPICAL
|
| The translation of the Route Code submitted by the firm, indicating route of administration. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources. |
Marketing Information:
An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
| Marketing Category: | UNAPPROVED HOMEOPATHIC |
| Product types are broken down into several potential Marketing Categories, such as New Drug Application (NDA), Abbreviated New Drug Application (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. |
| Marketing Start Date: | 15 Mar, 2013 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 24 Dec, 2025 |
| This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached. |
| Listing Expiration Date: | 31 Dec, 2023 |
| This is the date when the listing record will expire if not updated or certified by the firm. |
OpenFDA Information:
An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
| Manufacturer Name: | Forces of Nature
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| Original Packager: | Yes
|
| Whether or not the drug has been repackaged for distribution. |
| UNII: | 1NT28V9397
|
| Unique Ingredient Identifier, which is a non-proprietary, free, unique, unambiguous, non-semantic, alphanumeric identifier based on a substance’s molecular structure and/or descriptive information. |
Packaging Information:
| Package NDC | Description | Marketing Start Date | Marketing End Date | Sample Available |
|---|
| 51393-4006-1 | 11 mL in 1 BOTTLE, DISPENSING (51393-4006-1) | 15 Mar, 2013 | N/A | No |
| 51393-4006-2 | 33 mL in 1 BOTTLE, DISPENSING (51393-4006-2) | 15 Mar, 2013 | N/A | No |
| 51393-4006-4 | 4 mL in 1 BOTTLE, DISPENSING (51393-4006-4) | 01 Sep, 2018 | N/A | No |
| Package NDC number, known as the NDC, identifies the labeler, product, and trade package size. The first segment, the labeler code, is assigned by the FDA. Description tells the size and type of packaging in sentence form. Multilevel packages will have the descriptions concatenated together. |
Purpose:
Purpose remedy for rosacea. treats skin rashes.
Product Elements:
Rosacea thuja occidentalis leafy twig thuja occidentalis leafy twig thuja occidentalis leafy twig lavender oil rosa moschata oil melaleuca quinquenervia leaf oil chamomile flower oil tamanu oil hippophae rhamnoides fruit oil sesame oil
Indications and Usage:
Indications relieves and controls the symptoms of rosacea. eases itching, irritation, redness, and flaking of the skin or scalp.
Warnings:
Warnings for external use only. avoid contact with the eyes; if contact occurs, flush with water or rub towel moistened with a fatty oil such as sesame or olive oil over closed eye and seek advice from medical personnel. if condition worsens or does not improve after regular use of product as directed, consult a doctor. some individuals may be sensitive to tea tree or other oils. if you are pregnant or breastfeeding, ask a health professional before use. not to be used with children under 2 years of age without physician direction. keep all medicines out of the reach of children.
Do Not Use:
Warnings for external use only. avoid contact with the eyes; if contact occurs, flush with water or rub towel moistened with a fatty oil such as sesame or olive oil over closed eye and seek advice from medical personnel. if condition worsens or does not improve after regular use of product as directed, consult a doctor. some individuals may be sensitive to tea tree or other oils. if you are pregnant or breastfeeding, ask a health professional before use. not to be used with children under 2 years of age without physician direction. keep all medicines out of the reach of children.
Dosage and Administration:
Directions apply directly to affected areas as needed. recommend to cleanse area with an all-natural soap prior to application. for best results apply 2-3 times per day.
Package Label Principal Display Panel:
Principal display panel - 33 ml bottle label forces of nature ® rosacea control homeopathic medicine fda registered + usda organic 33ml principal display panel - 33 ml bottle label