Arnica

Arnica Montana Flower, Calendula Officinalis Flower, Hamamelis Virginiana Leaf, And Chamomile

Ona Stick Usa Llc
Human Otc Drug
NDC 82610-003

Arnica also known as Arnica Montana Flower, Calendula Officinalis Flower, Hamamelis Virginiana Leaf, And Chamomile is a human otc drug labeled by 'Ona Stick Usa Llc'. National Drug Code (NDC) number for Arnica is 82610-003. This drug is available in dosage form of Stick. The names of the active, medicinal ingredients in Arnica drug includes Arnica Montana Flower - 1 [hp_X]/14g Calendula Officinalis Flower - 1 [hp_X]/14g Chamomile - 1 [hp_X]/14g Hamamelis Virginiana Leaf - 1 [hp_X]/14g . The currest status of Arnica drug is Active.

Drug Information:

Drug NDC:	82610-003
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:	Arnica
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 Flower, Calendula Officinalis Flower, Hamamelis Virginiana Leaf, And Chamomile
Also known as the generic name, this is usually the active ingredient(s) of the product.
Labeler Name:	Ona Stick Usa Llc
Name of Company corresponding to the labeler code segment of the ProductNDC.
Dosage Form:	Stick
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 FLOWER - 1 [hp_X]/14g CALENDULA OFFICINALIS FLOWER - 1 [hp_X]/14g CHAMOMILE - 1 [hp_X]/14g HAMAMELIS VIRGINIANA LEAF - 1 [hp_X]/14g
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, 2022
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:	ONA STICK USA LLC
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:	OZ0E5Y15PZ P0M7O4Y7YD FGL3685T2X T07U1161SV
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
82610-003-14	1 TUBE in 1 BLISTER PACK (82610-003-14) / 14 g in 1 TUBE	15 Mar, 2022	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.

Other medicines with the same generic name

Arnica

Arnica Montana Flower & more..

Stick
ONA STICK USA LLC
NDC: 82610-003

Purpose:

Active ingredients purpose arnica montana (arnica) , 1x, 2.5% calendula officinalis (calendula) , 1x, 1.8% hamamelis virginiana (witch hazel) , 1x, 2.5% matricaria chamomilla (chamomile) , 1x, 2.0% for relief of minor pain, discomfort, bumps & bruises

Product Elements:

Arnica arnica montana flower, calendula officinalis flower, hamamelis virginiana leaf, and chamomile arnica montana flower arnica montana flower calendula officinalis flower calendula officinalis flower hamamelis virginiana leaf hamamelis virginiana leaf chamomile chamomile yellow wax carnauba wax castor oil cocoa butter coconut oil isopropyl myristate lanolin mineral oil oleic acid ceresin stearyl alcohol

Indications and Usage:

Uses as a homeopathic medicine, these "uses" have not been evaluated by the food & drug administration. temporarily relieves minor pain, discomfort, bumps and bruises due to minor injuries, falls, trauma and overexertion.

Warnings:

Warnings for external use only. do not use if you are allergic to any of the active ingredients or inactive ingredients in this product. when using this product avoid contact with eyes and mouth do not use on wounds or irritated or damaged skin use only as directed do not apply tight wraps or bandages to treated areas do not apply heat to treated areas immediately before or after use stop use and ask a doctor if symptoms persist more than 3 days or worsen symptoms clear up and then reoccur within a few days keep out of reach of children. if swallowed, get medical help or contact a poison control center right away.

Do Not Use:

When Using:

When using this product avoid contact with eyes and mouth do not use on wounds or irritated or damaged skin use only as directed do not apply tight wraps or bandages to treated areas do not apply heat to treated areas immediately before or after use

Dosage and Administration:

Directions apply a thin layer to affected areas, massaging onto skin. repeat as needed. if heat or ice are applied to skin, wait 10 minutes before applying product.

Stop Use:

Stop use and ask a doctor if symptoms persist more than 3 days or worsen symptoms clear up and then reoccur within a few days

Package Label Principal Display Panel:

Principal display panel - 14 g tube blister pack chamomile â¢ calendula â¢ witch hazel natural active ingredients arnica onÃ¡ stick Â® pain & bruise balm homeopathic medicine | wellness at hand. goodbye bruises! pain & bruise balm homeopathic medicine net wt 0.5 oz (14 g) principal display panel - 14 g tube blister pack

Further Questions:

Questions call 210.629.1343

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.