Triflora Gel

Urtica Dioica, Toxicodendron Pubescens Leaf, Ledum Palustre Twig

Schwabe Mexico S.a. De C.v.
Human Otc Drug
NDC 68466-1001

Triflora Gel also known as Urtica Dioica, Toxicodendron Pubescens Leaf, Ledum Palustre Twig is a human otc drug labeled by 'Schwabe Mexico S.a. De C.v.'. National Drug Code (NDC) number for Triflora Gel is 68466-1001. This drug is available in dosage form of Gel. The names of the active, medicinal ingredients in Triflora Gel drug includes Ledum Palustre Twig - 2 [hp_X]/78g Toxicodendron Pubescens Leaf - 3 [hp_X]/78g Urtica Dioica - 1 [hp_X]/78g . The currest status of Triflora Gel drug is Active.

Drug Information:

Drug NDC:	68466-1001
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:	Triflora Gel
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:	Urtica Dioica, Toxicodendron Pubescens Leaf, Ledum Palustre Twig
Also known as the generic name, this is usually the active ingredient(s) of the product.
Labeler Name:	Schwabe Mexico S.a. De C.v.
Name of Company corresponding to the labeler code segment of the ProductNDC.
Dosage Form:	Gel
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:	LEDUM PALUSTRE TWIG - 2 [hp_X]/78g TOXICODENDRON PUBESCENS LEAF - 3 [hp_X]/78g URTICA DIOICA - 1 [hp_X]/78g
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.
Route Details:	TOPICAL 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:	17 Dec, 2018
This is the date that the labeler indicates was the start of its marketing of the drug product.
Marketing End Date:	30 Dec, 2023
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:	16 Jan, 2025
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:	Schwabe Mexico S.A. de C.V.
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.
UPC:	0308078252971
UPC stands for Universal Product Code.
UNII:	877L01IZ0P 6IO182RP7A 710FLW4U46
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
68466-1001-4	1 TUBE in 1 CARTON (68466-1001-4) / 28 g in 1 TUBE	17 Dec, 2018	30 Dec, 2023	No
68466-1001-8	1 TUBE in 1 CARTON (68466-1001-8) / 78 g in 1 TUBE	17 Dec, 2018	30 Dec, 2023	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.

Other medicines with the same generic name

Triflora Gel

Urtica Dioica, Toxicodendron Pubescens Leaf, Ledum Palustre Twig

Gel
Schwabe Mexico S.A. de C.V.
NDC: 68466-1001

Triflora Gel

Urtica Dioica, Toxicodendron Pubescens Leaf, Ledum Palustre Twig

Gel
Schwabe Mexico S.A. de C.V.
NDC: 68466-2001

Purpose:

Purpose temporarily relieves minor aches, pains, and joint/muscle stiffness associated with arthritis, rheumatism, simple backache and tendinitis.

Product Elements:

Triflora gel urtica dioica, toxicodendron pubescens leaf, ledum palustre twig urtica dioica urtica dioica toxicodendron pubescens leaf toxicodendron pubescens leaf ledum palustre twig ledum palustre twig carbomer homopolymer type c alcohol pine needle oil (pinus sylvestris) water sodium hydroxide witch hazel

Indications and Usage:

Indications and usage temporarily relieves minor aches, pains, and joint/muscle stiffness associated with arthritis, rheumatism, simple backache and tendinitis.

Warnings:

Warning for external use only. avoid contact with eyes and broken skin.

Do Not Use:

Warning for external use only. avoid contact with eyes and broken skin.

Dosage and Administration:

Dosage and administration directions: adult and children 2 years of age and older: apply to affected area up to 4 times daily. rub in gently. children under 2 years of age: consult a doctor. patch test recommended on sensitive skin.

Stop Use:

Stop use stop use and ask a doctor if skin irritation, rash or other allergic reaction develops, condition worsens or does not improve within 7 days, symptoms clear up and occur again within a few days. these could be signs of a serious condition

Overdosage:

Overdosage if swallowed, seek medical help or contact a poison control center immediately.

Package Label Principal Display Panel:

Lbn21825297.a01 z triflora gel 2.75oz.jpg

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.