365 Everyday Value Arnica

Arnica Montana


Wfm Private Label, Lp
Human Otc Drug
NDC 42681-0512
365 Everyday Value Arnica also known as Arnica Montana is a human otc drug labeled by 'Wfm Private Label, Lp'. National Drug Code (NDC) number for 365 Everyday Value Arnica is 42681-0512. This drug is available in dosage form of Gel. The names of the active, medicinal ingredients in 365 Everyday Value Arnica drug includes Arnica Montana - 1 [hp_X]/1 . The currest status of 365 Everyday Value Arnica drug is Active.

Drug Information:

Drug NDC: 42681-0512
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: 365 Everyday Value 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
Also known as the generic name, this is usually the active ingredient(s) of the product.
Labeler Name: Wfm Private Label, Lp
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]/1
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: 01 Sep, 2008
This is the date that the labeler indicates was the start of its marketing of the drug product.
Marketing End Date: 15 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, 2024
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:WFM Private Label, LP
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:0099482426354
UPC stands for Universal Product Code.
UNII:O80TY208ZW
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
42681-0512-51 GEL in 1 BOX (42681-0512-5)01 Sep, 2008N/ANo
42681-0512-61 GEL in 1 BOX (42681-0512-6)15 Jan, 2021N/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:

Purpose* arnica montana 1x hpus - 7% ... trauma, bruises, stiffness, muscle soreness

Product Elements:

365 everyday value arnica arnica montana water alcohol carbomer homopolymer type c sodium hydroxide arnica montana arnica montana

Indications and Usage:

Uses* for relief of muscle aches and stiffness due to: minor injuries strains falls and blows reduces pain, swelling and discoloration from bruises

Warnings:

For external use only

Do Not Use:

For external use only

When Using:

When using this product avoid contact with eyes, mucous membranes, wounds, damaged or irritated skin use only as directed dryness or irritation may occur do not tightly wrap or bandage the treated area do not apply heat or ice to the treated area immediately before or after use

Dosage and Administration:

Directions apply a thin layer of arnica gel to affected area as soon as possible after minor injury. repeat 3 times a day or as needed. if heat or ice is applied, wait 5 minutes before applying arnica gel.

Package Label Principal Display Panel:

Label label box tube

Further Questions:

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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.