Wellheal

Aesculus Hipp, Calendula Off, Equisetum Arv, Symphytum Off, Salix Alba, Stellaria Med, Mezereum Off, Uritca Urens, Althaea Off, Hamamelis Vir


Proximity Capital Partners Llc Dba Asutra
Human Otc Drug
NDC 72683-001
Wellheal also known as Aesculus Hipp, Calendula Off, Equisetum Arv, Symphytum Off, Salix Alba, Stellaria Med, Mezereum Off, Uritca Urens, Althaea Off, Hamamelis Vir is a human otc drug labeled by 'Proximity Capital Partners Llc Dba Asutra'. National Drug Code (NDC) number for Wellheal is 72683-001. This drug is available in dosage form of Cream. The names of the active, medicinal ingredients in Wellheal drug includes Althaea Officinalis Root - 3 [hp_X]/g Calendula Officinalis Flowering Top - 3 [hp_X]/g Comfrey Root - 3 [hp_X]/g Daphne Mezereum Bark - 3 [hp_X]/g Equisetum Arvense Top - 3 [hp_X]/g Hamamelis Virginiana Root Bark/stem Bark - 3 [hp_X]/g Horse Chestnut - 3 [hp_X]/g Salix Alba Bark - 3 [hp_X]/g Stellaria Media - 3 [hp_X]/g Urtica Urens - 3 [hp_X]/g . The currest status of Wellheal drug is Active.

Drug Information:

Drug NDC: 72683-001
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: Wellheal
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: Aesculus Hipp, Calendula Off, Equisetum Arv, Symphytum Off, Salix Alba, Stellaria Med, Mezereum Off, Uritca Urens, Althaea Off, Hamamelis Vir
Also known as the generic name, this is usually the active ingredient(s) of the product.
Labeler Name: Proximity Capital Partners Llc Dba Asutra
Name of Company corresponding to the labeler code segment of the ProductNDC.
Dosage Form: Cream
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:ALTHAEA OFFICINALIS ROOT - 3 [hp_X]/g
CALENDULA OFFICINALIS FLOWERING TOP - 3 [hp_X]/g
COMFREY ROOT - 3 [hp_X]/g
DAPHNE MEZEREUM BARK - 3 [hp_X]/g
EQUISETUM ARVENSE TOP - 3 [hp_X]/g
HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK - 3 [hp_X]/g
HORSE CHESTNUT - 3 [hp_X]/g
SALIX ALBA BARK - 3 [hp_X]/g
STELLARIA MEDIA - 3 [hp_X]/g
URTICA URENS - 3 [hp_X]/g
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: 18 Mar, 2019
This is the date that the labeler indicates was the start of its marketing of the drug product.
Marketing End Date: 09 May, 2026
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:Proximity Capital Partners LLC dba Asutra
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:TRW2FUF47H
18E7415PXQ
M9VVZ08EKQ
X2N6E405GV
1DP6Y6B65Z
T7S323PKJS
3C18L6RJAZ
205MXS71H7
2H03479QVR
IHN2NQ5OF9
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 NDCDescriptionMarketing Start DateMarketing End DateSample Available
72683-001-011 TUBE in 1 CARTON (72683-001-01) / 28 g in 1 TUBE18 Mar, 2019N/ANo
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:

All active ingredients are hpus* in equal proportion at 2x potency aesculus hipp., calendula off., equisetum arv., symphytum off. ................................promotes wound healing salix alba, stellaria med. ......................................topical analgesic mezereum off., urtica urens ................................ reduces itching althaea off., hamamelis vir. .................................anti-inflammatory *hpus indicates active ingredients are in the official homeopathic pharmacopeia of the united states.

Product Elements:

Wellheal aesculus hipp, calendula off, equisetum arv, symphytum off, salix alba, stellaria med, mezereum off, uritca urens, althaea off, hamamelis vir equisetum arvense top equisetum arvense top salix alba bark salix alba bark stellaria media stellaria media aloe vera leaf adansonia digitata seed oil citric acid monohydrate methyl glucose dioleate urtica urens urtica urens horse chestnut horse chestnut comfrey root comfrey root daphne mezereum bark daphne mezereum bark althaea officinalis root althaea officinalis root hamamelis virginiana root bark/stem bark hamamelis virginiana root bark/stem bark carboxypolymethylene potassium sorbate water sodium hydroxide caprylyl glycol calendula officinalis flowering top calendula officinalis flowering top clove oil silver citrate hyaluronic acid

Indications and Usage:

Helps reduce potential infection in minor cuts, scrapes, and abrasions. for temporary relief of itchiness and soreness. promotes wound healing. indications are based on materia medica, not clinical tests.

Warnings:

For external use only. do not use if you have: deep or puncture wounds animal bites serious burns rash develops ----- do not use: over large areas of the body in eyes stop use and ask doctor if: condition worsens or lasts more than 1 week symptoms clear up and reoccur within a few days keep out of reach of children. if swallowed, get medical help or contact a poisin control center right away.

Do Not Use:

For external use only. do not use if you have: deep or puncture wounds animal bites serious burns rash develops ----- do not use: over large areas of the body in eyes stop use and ask doctor if: condition worsens or lasts more than 1 week symptoms clear up and reoccur within a few days keep out of reach of children. if swallowed, get medical help or contact a poisin control center right away.

Dosage and Administration:

Clean the affected area apply a small amount of this product on the area 2 to 3 times daily may be covered with a steril bandage

Stop Use:

Stop use and ask doctor if: condition worsens or lasts more than 1 week symptoms clear up and reoccur within a few days

Package Label Principal Display Panel:

001

Further Questions:

1-888-819-6472 monday - friday, 9am - 5pm ct report any serious side effects to number above.


Comments/ Reviews:

* Data of this site is collected from www.fda.gov. This page is for informational purposes only. Always consult your physician with any questions you may have regarding a medical condition.