Muscle Therapy With Arnica Pain Relief Gel

Arnica Montana,bellis Perennis,hypericum Perforatum,ruta Graveolensflowering Top And Rhododendron Tomentosum Leafy Twig


Hylands Inc.
Human Otc Drug
NDC 54973-3203
Muscle Therapy With Arnica Pain Relief Gel also known as Arnica Montana,bellis Perennis,hypericum Perforatum,ruta Graveolensflowering Top And Rhododendron Tomentosum Leafy Twig is a human otc drug labeled by 'Hylands Inc.'. National Drug Code (NDC) number for Muscle Therapy With Arnica Pain Relief Gel is 54973-3203. This drug is available in dosage form of Gel. The names of the active, medicinal ingredients in Muscle Therapy With Arnica Pain Relief Gel drug includes Arnica Montana - 1 [hp_X]/g Bellis Perennis - 2 [hp_X]/g Hypericum Perforatum - 2 [hp_X]/g Rhododendron Tomentosum Leafy Twig - 2 [hp_X]/g Ruta Graveolens Flowering Top - 2 [hp_X]/g . The currest status of Muscle Therapy With Arnica Pain Relief Gel drug is Active.

Drug Information:

Drug NDC: 54973-3203
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: Muscle Therapy With Arnica Pain Relief 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: Arnica Montana,bellis Perennis,hypericum Perforatum,ruta Graveolensflowering Top And Rhododendron Tomentosum Leafy Twig
Also known as the generic name, this is usually the active ingredient(s) of the product.
Labeler Name: Hylands Inc.
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:ARNICA MONTANA - 1 [hp_X]/g
BELLIS PERENNIS - 2 [hp_X]/g
HYPERICUM PERFORATUM - 2 [hp_X]/g
RHODODENDRON TOMENTOSUM LEAFY TWIG - 2 [hp_X]/g
RUTA GRAVEOLENS FLOWERING TOP - 2 [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: 27 Aug, 2018
This is the date that the labeler indicates was the start of its marketing of the drug product.
Marketing End Date: 24 Jun, 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:Hylands Inc.
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:O80TY208ZW
2HU33I03UY
XK4IUX8MNB
877L01IZ0P
N94C2U587S
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
54973-3203-11 TUBE in 1 CARTON (54973-3203-1) / 70.9 g in 1 TUBE27 Aug, 2018N/ANo
54973-3203-210 g in 1 PACKET (54973-3203-2)27 Aug, 2018N/AYes
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 temporarily relieves symptoms of pain, bruising, muscle soreness and swelling due to overexertion or injury.

Product Elements:

Muscle therapy with arnica pain relief gel arnica montana,bellis perennis,hypericum perforatum,ruta graveolensflowering top and rhododendron tomentosum leafy twig alcohol water sodium hydroxide arnica montana arnica montana bellis perennis bellis perennis hypericum perforatum hypericum perforatum ruta graveolens flowering top ruta graveolens flowering top rhododendron tomentosum leafy twig rhododendron tomentosum leafy twig light yellow to light tan

Indications and Usage:

Uses temporarily relieves the symptoms of pain, bruising, muscle soreness and swelling due to overexertion or injury.

Warnings:

Warnings for external use only. keep away from eyes. do not use on open wounds. stop use and ask a doctor if ■ pain gets worse or lasts more than 7 days. ■ new symptoms occur. ■ redness or swelling persists or worsens. if pregnant or breastfeeding ask a health professional before use. keep out of reach of children.

Do Not Use:

Warnings for external use only. keep away from eyes. do not use on open wounds. stop use and ask a doctor if ■ pain gets worse or lasts more than 7 days. ■ new symptoms occur. ■ redness or swelling persists or worsens. if pregnant or breastfeeding ask a health professional before use. keep out of reach of children.

Dosage and Administration:

Directions adults and children 6 years and over: ■ apply liberally to affected area. ■ repeat until relieved, up to 4 times per day. ■ do not use other than directed.

Stop Use:

Stop use and ask a doctor if ■ pain gets worse or lasts more than 7 days. ■ new symptoms occur. ■ redness or swelling persists or worsens.

Package Label Principal Display Panel:

Principal display panel - 70.9 grams gel tube carton hyland's naturals™ muscle therapy -with arnica- pain relief gel* soreness swelling stiffness bruising homeopathic 2.5 oz. (70.9 grams) carton

Further Questions:

Questions? www.hylands.com or (800) 624-9659


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.