Gr Arthritis Pain Relief Roll-on 1500 Mg
Pain Relief
Clarity Labs Llc
Human Otc Drug
NDC 78232-005Gr Arthritis Pain Relief Roll-on 1500 Mg also known as Pain Relief is a human otc drug labeled by 'Clarity Labs Llc'. National Drug Code (NDC) number for Gr Arthritis Pain Relief Roll-on 1500 Mg is 78232-005. This drug is available in dosage form of Lotion. The names of the active, medicinal ingredients in Gr Arthritis Pain Relief Roll-on 1500 Mg drug includes Camphor (synthetic) - 4 g/100g Menthol - 8 g/100g . The currest status of Gr Arthritis Pain Relief Roll-on 1500 Mg drug is Active.
Drug Information:
| Drug NDC: | 78232-005 |
| 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: | Gr Arthritis Pain Relief Roll-on 1500 Mg |
| 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: | Pain Relief |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Clarity Labs Llc |
| 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: | CAMPHOR (SYNTHETIC) - 4 g/100g
MENTHOL - 8 g/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: | OTC MONOGRAPH FINAL |
| 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: | 05 Apr, 2022 |
| 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. |
| Application Number: | part346 |
| This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null. |
| 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: | Clarity Labs 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: | 5TJD82A1ET
L7T10EIP3A
|
| 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 |
|---|
| 78232-005-03 | 363.6 BOX in 1 CARTON (78232-005-03) / 90.9 TUBE, WITH APPLICATOR in 1 BOX (78232-005-02) / 90.9 g in 1 TUBE, WITH APPLICATOR (78232-005-01) | 05 Apr, 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:
Purpose topical analgesic, pain relief lotion
Product Elements:
Gr arthritis pain relief roll-on 1500 mg pain relief oenothera biennis flowering top equisetum arvense whole harpagophytum procumbens root water carthamus tinctorius (safflower) oleosomes black cohosh ethylhexylglycerin menthol menthol phenoxyethanol avocado oil cannabidiol symphytum officinale whole bentonite camphor (synthetic) camphor (synthetic) stellaria media
Indications and Usage:
Use pain relief lotion to help reduce minor aches and pains of muscles and joints associated with: arthritis, strains, sprains, simple backaches, and bruises.
Warnings:
Avoid contact with eyes do not bandage tightly do not apply to wounds or damaged skin for external use only
Do Not Use:
Avoid contact with eyes do not bandage tightly do not apply to wounds or damaged skin for external use only
When Using:
This product is for external use only. when using this product keep out of eyes, ears, and mouth. in case of contact with eyes, rinse eyes thoroughly with water. do not bandage tightly when applying this product. do not apply this product more than 4 times per day. stop use and ask a doctor if irritation or rash occurs. if condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days, discontinue use of this product and consult a physician. keep out of reach of children. if swallowed, get medical help or contact a poison control center right away.
Dosage and Administration:
Directions this product is for external use only. rub the affected area accordingly. apply to affected area no more than 3 to 4 times daily.
Stop Use:
Stop use and ask a doctor if irritation or rash occurs. if condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days, discontinue use of this product, and consult a physician.
Package Label Principal Display Panel:
Design and label of container tube label tube label
Package label display box (ifc) ifc individual folding carton ifc label
Most outer box big container box outer box
Further Questions:
Manufacturing and distributors information manufactured and distributed by: green roads of florida, llc 601 fairway dr, deerfield beach, fl 33441 833-462-8922 greenroads.com