Real Time Pain Relief Select Plus Hemp Oil
Arnica Montana
Cosmetic Specialty Labs, Inc.
Human Otc Drug
NDC 58133-800Real Time Pain Relief Select Plus Hemp Oil also known as Arnica Montana is a human otc drug labeled by 'Cosmetic Specialty Labs, Inc.'. National Drug Code (NDC) number for Real Time Pain Relief Select Plus Hemp Oil is 58133-800. This drug is available in dosage form of Lotion. The names of the active, medicinal ingredients in Real Time Pain Relief Select Plus Hemp Oil drug includes Arnica Montana - 3 [hp_X]/mL . The currest status of Real Time Pain Relief Select Plus Hemp Oil drug is Active.
Drug Information:
| Drug NDC: | 58133-800 |
| 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: | Real Time Pain Relief Select Plus Hemp Oil |
| 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: | Cosmetic Specialty Labs, Inc. |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Lotion |
| 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 - 3 [hp_X]/mL
|
| 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 Jan, 2015 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 15 Jan, 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: | Cosmetic Specialty Labs, 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: | 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 |
|---|
| 58133-800-03 | 88 mL in 1 BOTTLE, WITH APPLICATOR (58133-800-03) | 01 Jan, 2015 | 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 bruising, stiffness, pain *the letters h.p.u.s. indicate that the components in this product are officially monographed in the homeopathic pharmacopoeia of the united states.
Product Elements:
Real time pain relief select plus hemp oil arnica montana arnica montana arnica montana aloe vera leaf dimethyl sulfone cetostearyl alcohol triethanolamine tris(dihydrogen phosphate) calendula officinalis seed oil tilia cordata flower centaurea cyanus flower water sorbitol cetyl alcohol hamamelis virginiana root bark/stem bark rubus idaeus seed phenoxyethanol caprylyl glycol carbomer 940 salix alba bark hemp capsicum frutescens whole hypericum perforatum alcohol butylene glycol menthol chamomile matricaria chamomilla flowering top oil coriandrum sativum whole
Indications and Usage:
Uses temporarily relieves symptoms of muscle pain, soreness, bruising and swelling due to overexertion or injury.
Warnings:
Warnings for external use only
When Using:
When using this product avoid contact with eyes if swallowed, get medical help or contact a poison control center immediately. test for allergy by rubbing small amount on skin first. do not use if allergic to or hypersensitive to any ingredient. if condition worsens or does not improve consult a doctor.
Dosage and Administration:
Directions: apply to affected area 2 times daily or as needed.
Stop Use:
Stop use and ask a doctor if: condition worsens symptoms persist for more than 7 days or clear up and occur again within a few days redness is present irritation develops
Package Label Principal Display Panel:
Principal display panel and drug facts labeling