Arnicare
Arnica Montana
Laboratoires Boiron
Human Otc Drug
NDC 0220-9000Arnicare also known as Arnica Montana is a human otc drug labeled by 'Laboratoires Boiron'. National Drug Code (NDC) number for Arnicare is 0220-9000. This drug is available in dosage form of Gel. The names of the active, medicinal ingredients in Arnicare drug includes Arnica Montana - 1 [hp_X]/g . The currest status of Arnicare drug is Active.
Drug Information:
| Drug NDC: | 0220-9000 |
| 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: | Arnicare |
| 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: | Laboratoires Boiron |
| 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
|
| 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: | 09 Jan, 2007 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 15 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, 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: | Laboratoires Boiron
|
| 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
|
| 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 |
|---|
| 0220-9000-54 | 1 TUBE in 1 PACKAGE (0220-9000-54) / 45 g in 1 TUBE | 09 Jan, 2007 | N/A | No |
| 0220-9000-59 | 1 TUBE in 1 PACKAGE (0220-9000-59) / 75 g in 1 TUBE | 09 Jan, 2007 | N/A | No |
| 0220-9000-65 | 1 TUBE in 1 PACKAGE (0220-9000-65) / 14 g in 1 TUBE | 09 Jan, 2007 | N/A | No |
| 0220-9000-66 | 1 TUBE in 1 PACKAGE (0220-9000-66) / 120 g in 1 TUBE | 09 Jan, 2007 | N/A | No |
| 0220-9000-84 | 1 TUBE in 1 PACKAGE (0220-9000-84) / 45 g in 1 TUBE | 01 Jun, 2018 | N/A | No |
| 0220-9000-86 | 2 TUBE in 1 PACKAGE (0220-9000-86) / 45 g in 1 TUBE | 01 Jun, 2018 | 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. |
Purpose:
Purpose* arnica montana 1x hpus relieves muscle pain and stiffness, swelling from injuries, discoloration from bruises
Product Elements:
Arnicare arnica montana alcohol water sodium hydroxide carbomer homopolymer type c arnica montana arnica montana
Indications and Usage:
Uses* temporarily relieves muscle pain and stiffness due to: minor injuries overexertion falls reduces symptoms of bruising such as: pain swelling discoloration
Warnings:
Warnings for external use only. do not use if you are allergic to arnica montana or to any of this product's inactive ingredients. 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 treated area immediately before or after use.
Dosage and Administration:
Directions apply a thin layer of arnicare gel to the 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 arnicare gel arnicare gel roll-on - shake well before each use. with the applicator facing down, lightly squeeze the tube then roll ball against skin to apply a thin layer of the product to affected area. massage gently into skin 3 times a day or as needed. if heat or ice is applied, wait 5 minutes before applying arnicare roll-on.
Stop Use:
Stop use and ask a doctor if condition persists for more than 3 days or worsens symptoms clear up and occur again within a few days.
Package Label Principal Display Panel:
Label label label label label label label label label label label label label label 12.27.19 label label label tube box box 2.6 1.5 5th panel sample 4.1
Further Questions:
Questions, comments? distributed by boiron, inc., newtown square, pa 19073 1-800-boiron-1 (1-800-264-7661) arnicare.com made in france