Arnica Silver Plus
Arnica Montana, Calendula Officinalis
Recovery Care Products Llc
Human Otc Drug
NDC 72525-005Arnica Silver Plus also known as Arnica Montana, Calendula Officinalis is a human otc drug labeled by 'Recovery Care Products Llc'. National Drug Code (NDC) number for Arnica Silver Plus is 72525-005. This drug is available in dosage form of Gel. The names of the active, medicinal ingredients in Arnica Silver Plus drug includes Arnica Montana - 6 [hp_X]/100g Calendula Officinalis Flowering Top - 6 [hp_X]/100g . The currest status of Arnica Silver Plus drug is Active.
Drug Information:
| Drug NDC: | 72525-005 |
| 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 Silver Plus |
| Also known as the trade name. It is the name of the product chosen by the labeler. |
| Proprietary Name Base: | Arnica Silver |
| The base of the Brand/Proprietary name excluding its suffix. |
| Proprietary Name Suffix: | PLUS |
| A suffix to the proprietary name, a value here should be appended to the ProprietaryName field to obtain the complete name of the product. This suffix is often used to distinguish characteristics of a product such as extended release (“XR”) or sleep aid (“PM”). Although many companies follow certain naming conventions for suffices, there is no recognized standard. |
| 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, Calendula Officinalis |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Recovery Care Products Llc |
| 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 - 6 [hp_X]/100g
CALENDULA OFFICINALIS FLOWERING TOP - 6 [hp_X]/100g
|
| 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: | 08 Dec, 2020 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 22 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: | Recovery Care Products LLC
|
| 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
18E7415PXQ
|
| 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 |
|---|
| 72525-005-01 | 99 g in 1 BOTTLE, PUMP (72525-005-01) | 08 Dec, 2020 | 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 promotes rapid wound repair & maintains healthy tissue in times of physical stress
Product Elements:
Arnica silver plus arnica montana, calendula officinalis aloe vera leaf water silver phenoxyethanol caprylyl glycol sorbic acid carbomer interpolymer type a (allyl sucrose crosslinked) sodium hydroxide sodium bicarbonate arnica montana arnica montana calendula officinalis flowering top calendula officinalis flowering top
Indications and Usage:
Uses: otc use for abrasions, lacerations & soft tissue injuries. under the supervision of a healthcare professional in the management of: stage i-iv pressure ulcers, partial and full thickness wounds, diabetic foot and leg ulcers , grafted and donor sites, 1st and 2nd degree burns safe for a wide variety of dermal applications. wound care: prevents & treats infections - provides moist healing environment - controls odor, pus & body exudation â minimizes abnormal scarring â protects incisions soft tissue trauma: reduces bruising, swelling & pain redness & itch relief: related to wound healing, scabs, burns (including sunburn, radiation, lasers), rashes, dry skin, eczema, bug bites, dry skin, hives, stretch marks, hair removal hair removal: soothes, cools & relieves itch on shaven, waxed or lasered skin everyday skin care: calms dry, sensitive, compromised, inflammatory & acne-prone skin anti-aging: regenerates, rejuvenates & revitalizes skin tissue. may reduce the appearance o
Read more...f fine lines & wrinkles and improve skin elasticity & resiliency
Warnings:
Warnings: for external use only. do not get into eyes. ⢠keep out of reach of children.
Dosage and Administration:
Directions: please adhere to your physician's protocol for this product. cleanse or debride wound as necessary with mild soap such as rcp gentle cleanser face & body foam wash. pat dry. apply a generous layer over affected area with clean hands or medical gloves. repeat as needed. for optimal results use in conjunction with rcp arnica montana+ & rcp pure bromelain.
Package Label Principal Display Panel:
01b lbl_arnica silver gel_front 01b uc_arnica silver gel_back