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| Product NDC Code | 73486-101 | ||||||
|---|---|---|---|---|---|---|---|
| Drug Name | Medirelief ultra |
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| Type | Brand | ||||||
| Active Ingredients |
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| Route | TOPICAL | ||||||
| Dosage Form | PATCH | ||||||
| RxCUI drug identifier | 420222 | ||||||
| Application Number | M017 | ||||||
| Labeler Name | FARLA MEDICAL HEALTHCARE LTD | ||||||
| Packages |
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| Check if available Online | Get Medication Prices online with Discount |
Active ingredient
A list of the active, medicinal ingredients in the drug product.Active Ingredients & Purpose
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 carboxymethylcellulose, dihydroxyaluminum aminoacetate, glycerin, kaolin, methylparaben, mineral oil, petrolatum, polyacrylic acid, polysorbate 80, povidone, propylene glycol, propylparaben, sodium polyacrylate, tartaric acid, titanium dioxide, water.
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 backache arthritis strains sprains
Purpose
Information about the drug product’s indications for use.Active ingredients (in each patch) Purpose Menthol 5%................................................................................................................................................................. Topical analgesic
| Topical analgesic |
Spl product data elements
Usually a list of ingredients in a drug product.MediRelief Ultra Menthol GLYCERIN SODIUM POLYACRYLATE (8000 MW) MENTHOL, UNSPECIFIED FORM MENTHOL, UNSPECIFIED FORM PROPYLPARABEN PROPYLENE GLYCOL WATER DIHYDROXYALUMINUM AMINOACETATE POVIDONE METHYLPARABEN KAOLIN POLYSORBATE 80 POLYACRYLIC ACID (8000 MW) TITANIUM DIOXIDE TARTARIC ACID PETROLATUM CARBOXYMETHYLCELLULOSE MINERAL OIL
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.Principal Display Panel (Medium) Patch NDC 73486-101-25 (Large) Patch NDC 73486-101-35 Large Patches Medium Patches
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 Ingredients & Purpose Active ingredients (in each patch) Purpose Menthol 5%................................................................................................................................................................. Topical analgesic
| Topical analgesic |
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 redness is present 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 of 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. 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 redness is present symptoms persist for more than 7 days or clear up and occur again within a few days If pregnant of 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.
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