Walgreens Arnica
Arnica Montana 7%
Walgreens
Human Otc Drug
NDC 0363-3034Walgreens Arnica also known as Arnica Montana 7% is a human otc drug labeled by 'Walgreens'. National Drug Code (NDC) number for Walgreens Arnica is 0363-3034. This drug is available in dosage form of Aerosol, Spray. The names of the active, medicinal ingredients in Walgreens Arnica drug includes Arnica Montana - 1 [hp_X]/g . The currest status of Walgreens Arnica drug is Active.
Drug Information:
| Drug NDC: | 0363-3034 |
| 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: | Walgreens 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 7% |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Walgreens |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Aerosol, Spray |
| 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: | 01 Nov, 2022 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 25 Dec, 2025 |
| 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: | Walgreens
|
| 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: | 0311917010953
|
| 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 NDC | Description | Marketing Start Date | Marketing End Date | Sample Available |
|---|
| 0363-3034-07 | 113 g in 1 BOTTLE, SPRAY (0363-3034-07) | 01 Nov, 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. |
Purpose:
Trauma, muscle pain and stiffness, swelling from injuries, discoloration from bruising
Product Elements:
Walgreens arnica arnica montana 7% arnica montana arnica montana isopropyl alcohol sodium hydroxide norflurane water carbomer 940 phenoxyethanol
Indications and Usage:
Temporarily relieves muscle pain and stiffness due to minor injuries, overexertion and falls reduces pain, swelling and discoloration from bruises.
Warnings:
For external use only do not use if you are allergic to arnica montana or to any of this product's inactive ingredients. extremely flammable do not use near heat or flame or while smoking avoid long term storage above 104°f (40°c) do not puncture or incinerate. contents under pressure do not store at temperatures above 120°f (49°c) when using this product use only as directed avoid spraying on face avoid inhalation of spray do not bandage or apply local heat (such as heating pads) or a medicated patch to area of use stop use and ask a doctor if irritation develops condition persist for more than 3 days or worsens if pregnant or breast feeding , ask a health professional before use. keep out of reach of children. if swallowed, get medical help or contact a poison control center right away.
Do Not Use:
For external use only do not use if you are allergic to arnica montana or to any of this product's inactive ingredients. extremely flammable do not use near heat or flame or while smoking avoid long term storage above 104°f (40°c) do not puncture or incinerate. contents under pressure do not store at temperatures above 120°f (49°c) when using this product use only as directed avoid spraying on face avoid inhalation of spray do not bandage or apply local heat (such as heating pads) or a medicated patch to area of use stop use and ask a doctor if irritation develops condition persist for more than 3 days or worsens if pregnant or breast feeding , ask a health professional before use. keep out of reach of children. if swallowed, get medical help or contact a poison control center right away.
When Using:
When using this product use only as directed avoid spraying on face avoid inhalation of spray do not bandage or apply local heat (such as heating pads) or a medicated patch to area of use
Dosage and Administration:
Directions: adults and children over 12 years: apply to affected area and massage until thoroughly absorbed into skin. repeat 3 times a day or as needed. children 12 years or younger : ask a doctor
Package Label Principal Display Panel:
Package carton
Further Questions:
Questions or comments ? 1-800-925-4733