Cvs Arnica
Arnica Montana Flower
Natural Essentials, Inc.
Human Otc Drug
NDC 66902-778Cvs Arnica also known as Arnica Montana Flower is a human otc drug labeled by 'Natural Essentials, Inc.'. National Drug Code (NDC) number for Cvs Arnica is 66902-778. This drug is available in dosage form of Gel. The names of the active, medicinal ingredients in Cvs Arnica drug includes Arnica Montana Flower - 1 [hp_X]/73g . The currest status of Cvs Arnica drug is Active.
Drug Information:
| Drug NDC: | 66902-778 |
| 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: | Cvs 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 |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Natural Essentials, Inc. |
| 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 FLOWER - 1 [hp_X]/73g
|
| 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: | 27 Jan, 2021 |
| 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: | Natural Essentials, Inc.
|
| 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
|
| 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 |
|---|
| 66902-778-26 | 1 TUBE in 1 CARTON (66902-778-26) / 73 g in 1 TUBE | 27 Jan, 2021 | 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* bruises & muscle soreness
Product Elements:
Cvs arnica arnica montana flower arnica montana flower arnica montana flower caprylyl glycol carbomer homopolymer type c (allyl pentaerythritol crosslinked) peg-8 dimethicone phenoxyethanol alcohol sodium hydroxide water
Indications and Usage:
Uses* homeopathic remedy/medicine temporarily relieves muscle pain and stiffness due to minor injuries; reduces pain, swelling and discoloration from bruises.
Warnings:
Warnings for external use only when using this product use only as directed do not use with other topical products. do not bandage tightly or use a heating pad. stop use and ask a doctor if a rash or other adverse reaction occurs. symptoms worsen or persist for more than 7 days. avoid contact with eyes or mucous membranes, damaged skin or wounds. do not use if you are allergic to arnica montana or to any of this product's inactive ingredients. if pregnant or breast feeding, ask a physician before use. keep out of reach of children and pets, if swallowed, seek professional help and contact poison control center right away.
When Using:
When using this product use only as directed do not use with other topical products. do not bandage tightly or use a heating pad.
Dosage and Administration:
Directions adults and children 12 years and older: apply & gently massage painful or bruised areas repeat as needed, no more than 4 times a day wash hands after each use with cold water store in a cool, dry area - close cap tight children under 12: ask your doctor.
Stop Use:
Stop use and ask a doctor if a rash or other adverse reaction occurs. symptoms worsen or persist for more than 7 days. avoid contact with eyes or mucous membranes, damaged skin or wounds. do not use if you are allergic to arnica montana or to any of this product's inactive ingredients.
Package Label Principal Display Panel:
Principal display panel - 73 g carton label cvs health ® compare to the active ingredient in arnicare ® gel** arnica gel relief for pain, stiffness & swelling* homeopathic absorbs quickly unscented non-greasy paraben free package contains one tube net wt 2.6 oz (73 g) *claims based on traditional homeopathic practice, not accepted medical evidence. not fda evaluated. principal display panel - 73 g carton label
Principal display panel - 73 g tube label cvs health ® arnica gel relief for pain, stiffness & swelling* homeopathic absorbs quickly unscented non-greasy paraben free net wt 2.6 oz (73 g) *claims based on traditional homeopathic practice, not accepted medical evidence. not fda evaluated. principal display panel - 73 g tube label