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| Product NDC Code | 83559-005 | ||||||
|---|---|---|---|---|---|---|---|
| Drug Name | Pain relief patch |
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| Type | Generic | ||||||
| Pharm Class | Allergens [CS], Cell-mediated Immunity [PE], Dietary Proteins [CS], Increased Histamine Release [PE], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS], Vegetable Proteins [CS] |
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| Active Ingredients |
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| Route | TOPICAL | ||||||
| Dosage Form | PATCH | ||||||
| Application Number | M017 | ||||||
| Labeler Name | Henan Enokon Medical Instrument Co., 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 Ingredient Camphor 80mg Menthol 24mg Capsicum Extract 16mg
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 and children 12 years and over apply to affected area; change patch 1 to 2 times daily ·Children under 12 years, consult doctor before use How to apply: ·Clean and dry affected area ·Cut open pouch and remove patch ·Remove protective film and apply directly to area of pain ·Apply to affected area not more than 3 times daily ·Wash hands with soap after applying patch ·Reseal pouch containing unused patches
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients Aluminum Glycinate, Ethylhexylglycerin, Eucalyptus Oil, Glycerin, Kaolin, Mentha Oil, Phenoxyethanol, Polyvinylpyrrolidone,Propylene Glycol, Sodium Carboxymethylcellulose, Sodium Polyacrylate, Sorbitol Solution, Tartaric Acid, 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.Use For temporary relief of pains
Purpose
Information about the drug product’s indications for use.Purpose Topical analgesic
Spl product data elements
Usually a list of ingredients in a drug product.Pain Relief Patch Pain Relief Patch DIHYDROXYALUMINUM AMINOACETATE ANHYDROUS CAMPHOR (SYNTHETIC) CAMPHOR (SYNTHETIC) CAPSICUM CAPSICUM KAOLIN PEPPERMINT OIL SORBITOL SOLUTION WATER GLYCERIN CARBOXYMETHYLCELLULOSE SODIUM PHENOXYETHANOL SODIUM ACRYLATE PROPYLENE GLYCOL ETHYLHEXYLGLYCERIN POVIDONE TARTARIC ACID MENTHOL MENTHOL EUCALYPTUS 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 1 3 2 4
Ask doctor
Information about when a doctor should be consulted about existing conditions or sumptoms before using the drug product, including all warnings for persons with certain preexisting conditions (excluding pregnancy) and all warnings for persons experiencing certain symptoms. The warnings under this heading are those intended only for situations in which consumers should not use the product until a doctor is consulted.Ask Doctor If pregnant or breast-feeding, or if you have sensitive skin, ask a healthcare professional before use. Children under 12 years, consult doctor before use
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 ·Do not get into eyes or on mucous membranes ·Do not apply to wounds, damaged or irritated skin ·Do not bandage or cover with any type of wrap except clothing ·Do not use with a heating pad or apply external heat ·Do not use 1 hour prior to bathing or within 30 minutes after bathing
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 Poison Control Center right away.
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions 1-800-910-6874
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 ·Condition worsens ·Severe skin irritation occurs ·Pain persists for more than 7 days ·Symptoms clear up and occur again within a few days
When using
Information about side effects that people may experience, and the substances (e.g. alcohol) or activities (e.g. operating machinery, driving a car) to avoid while using the drug product.When Using ·Use only as directed
Storage and handling
Information about safe storage and handling of the drug product.Other information This product may cause allergic reaction on some individuals.Store in cool dry place away from direct sunlight.
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
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