Arnica Value Pack
Arnica Montana
Laboratoires Boiron
Human Otc Drug
NDC 0220-9047Arnica Value Pack also known as Arnica Montana is a human otc drug labeled by 'Laboratoires Boiron'. National Drug Code (NDC) number for Arnica Value Pack is 0220-9047. This drug is available in dosage form of Kit. The names of the active, medicinal ingredients in Arnica Value Pack drug includes . The currest status of Arnica Value Pack drug is Active.
Drug Information:
| Drug NDC: | 0220-9047 |
| 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 Value Pack |
| 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: | Kit |
| 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: | |
| This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted. |
| Route Details: | |
| 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 Nov, 2008 |
| 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, 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: | |
| 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 |
|---|
| 0220-9047-78 | 1 KIT in 1 BOX (0220-9047-78) * 80 PELLET in 1 TUBE * 70 g in 1 TUBE | 01 Nov, 2008 | 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:
Cream: arnica montana 1x hpus-7% ..... trauma, muscle, pain and stiffness, swelling from injuries, discoloration from bruising. pellets: arnica montana 30c hpus .......... trauma, bruises and muscle soreness.
Product Elements:
Arnica value pack arnica montana arnica arnica montana sucrose lactose arnica montana arnica montana pellet ; arnicare arnica montana caprylyl glycol carbomer 934 cetyl palmitate edetate disodium water sodium hydroxide sorbic acid 1,2-hexanediol glycerin pegoxol 7 stearate alcohol arnica montana arnica montana hydrogenated palm/palm kernel oil peg-6 esters
Drug Interactions:
Unscented -paraben free -great for massage - works naturally with your body.
Indications and Usage:
Arnicare cream and arnica 30 c pellets temporary relieves muscle pain and stiffness due to minor injuries, overexertion and falls. reduces pain, swelling and discoloration from bruises.
Warnings:
Arnicare cream: for external use only. avoid contact with eyes and with open wounds.
When Using:
Avoid contact with eyes, mucus membranes, wounds, damaged or irrated skin use only as directed do not tightly wrap or bandage the treated area do not apply heat or ice to the trated area immediately before or after use
Dosage and Administration:
Cream: apply a thin layer of arnicare cream of affected area and massage gently 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 cream. pellets: adults and children 2 years of age and older: dissolve 5 pellets in the mouth 3 times a day until relieved or as directed by a doctor. how to use arnica 30c pellets: turn tube upside down. twist until 5 pellets are dispensed how to use arnica 30c pellets tube instructions added
Stop Use:
Cream: stop use and ask a doctor if condition persists for more than 3 days or worsens. pellets: stop use and ask a doctor if condition persists for more than 3 days or worsens.
Drug Interactions:
Unscented -paraben free -great for massage - works naturally with your body.
How Supplied:
Cream: 1 tube 2.5 oz (70g) pellets: 1 tube approx. 80 pellets each, 3.8g (0.133 oz.)
Package Label Principal Display Panel:
Label value pack box non edta box tube
Further Questions:
Questions, comments www.arnicare.com info@boironusa.com 1-800-boiron-1 (1-800-264-7661)