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| Product NDC Code | 73486-100 | ||||
|---|---|---|---|---|---|
| Drug Name | Medirelief hot |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | PATCH | ||||
| RxCUI drug identifier | 1043399 | ||||
| Application Number | M017 | ||||
| Labeler Name | Farla Medical Healthcare LTD | ||||
| Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredient & Purpose Active ingredients (in each patch) Purpose Capsaicin 0.025%........................................................................................................................................................ Topical analgesic
Dosage and administration
Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.Directions adults & children 12 years of age and older: apply to affected area not more than 3 to 4 times daily children under 12 years of age: consult a doctor
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients hydrogenated poly (C6-20 olefin), mineral oil, pentaerythrityl tetra-di-t-butyl hydroxyhydrocinnamate, styrene/isoprene copolymer
Indications and usage
A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.Uses For the temporary relief of minor aches and pains of muscles and joints associated with simple back aches arthritis strains sprains
Purpose
Information about the drug product’s indications for use.Active ingredients (in each patch) Purpose Capsaicin 0.025%........................................................................................................................................................ Topical analgesic
Spl product data elements
Usually a list of ingredients in a drug product.MediRelief Hot Capsaicin CAPSAICIN CAPSAICIN MINERAL OIL PENTAERYTHRITOL 3,5-DI-TERT-BUTYL-4-HYDROXYHYDROCINNAMATE STYRENE/ISOPRENE/STYRENE BLOCK COPOLYMER HYDROGENATED C6-20 POLYOLEFIN (100 CST)
Package label principal display panel
The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.Pricipal Display Panel MediRelief a Farla brand Hot Penetrating Pain Relief Patch Capsaicin 0.025% TEMPORARY RELIEF OF MINOR ACHES AND PAINS: • ARTHRITIS • BACKACHES • SPRAINS • STRAINS 1 Patch (Large) 5.1 in. x 7.1 in. (13 cm x 18 cm) Farla Medical MediRelief Cap
Spl unclassified section
Information not classified as belonging to one of the other fields. Approximately 40% of labeling with effective_time between June 2009 and August 2014 have information in this field.Drug Facts Active ingredient & Purpose Active ingredients (in each patch) Purpose Capsaicin 0.025%........................................................................................................................................................ Topical analgesic Uses For the temporary relief of minor aches and pains of muscles and joints associated with simple back aches arthritis strains sprains Warnings FOR EXTERNAL USE ONLY. Avoid contact with the eyes. Do not use on wounds or damaged skin on a tight bandage with a heating pad on sensitive skin if allergic to any ingredients in this product 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 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. Directions adults & children 12 years of age and older: apply to affected area not more than 3 to 4 times daily children under 12 years of age: consult a doctor Other information store at room temperature 68-77°F (20-25°C) do not store in direct sunlight or expose to excessive heat and moisture TAMPER EVIDENT: Do not use if pouch containing the patch is torn or broken. Inactive ingredients hydrogenated poly (C6-20 olefin), mineral oil, pentaerythrityl tetra-di-t-butyl hydroxyhydrocinnamate, styrene/isoprene copolymer Manufactured for & Distributed by: Manufactured for: Farla International Ltd., Unit 2, Staples Corner Business Park, 1000 North Circular Road, London NW2 7JP Tel +1 (844) 280-8400 [email protected] - www.farlainternational.com Distributed by: Platinum Care 240 52nd Street, Brooklyn, NY 11220 Tel: +1-718-435-2072
Do not use
Information about all contraindications for use. These contraindications are absolute and are intended for situations in which consumers should not use the product unless a prior diagnosis has been established by a doctor or for situations in which certain consumers should not use the product under any circumstances regardless of whether a doctor or health professional is consulted.Do not use on wounds or damaged skin on a tight bandage with a heating pad on sensitive skin if allergic to any ingredients in this product
Keep out of reach of children
Information pertaining to whether the product should be kept out of the reach of children, and instructions about what to do in the case of accidental contact or ingestion, if appropriate.KEEP OUT OF REACH OF CHILDREN. If swallowed, get medical help or contact a Poison Control Center right away.
Other safety information
Information about safe use and handling of the product that may not have been specified in another field.Other information store at room temperature 68-77°F (20-25°C) do not store in direct sunlight or expose to excessive heat and moisture TAMPER EVIDENT: Do not use if pouch containing the patch is torn or broken.
Stop use
Information about when use of the drug product should be discontinued immediately and a doctor consulted. Includes information about any signs of toxicity or other reactions that would necessitate immediately discontinuing use of the product.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
Pregnancy or breast feeding
Pregnancy or Breast feedingIf pregnant or breast-feeding, ask a health professional before use.
Warnings
Information about serious adverse reactions and potential safety hazards, including limitations in use imposed by those hazards and steps that should be taken if they occur.Warnings FOR EXTERNAL USE ONLY. Avoid contact with the eyes.
Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API