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Product NDC Code | 83391-002 | ||||||||
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Drug Name | Auvon pain relief |
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Type | Brand | ||||||||
Active Ingredients |
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Route | TOPICAL | ||||||||
Dosage Form | PATCH | ||||||||
RxCUI drug identifier | 420222 | ||||||||
Application Number | part348 | ||||||||
Labeler Name | SHENZHEN YUWEN E-COMMERCE CO., LTD. | ||||||||
Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active i ngredient s Menthol 5%
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 ■ Clean and dry the patch application area (no wound or hair), pull to separate the film, peel off one side of the film, apply the exposed patch to the skin, peel off the other side of the film, and press the patch firmly to the skin. ■ Do not repeatedly use or repeatedly reapply the patch as far as possible ■ Cut first if if used on joints ■ Use in te affected area no more than 4 times daily ■ Wash hands with cool water after use
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients Glycerin, sodium polyacrylate, dihydroxyaluminum aminoacetate, methylparaben, propylparaben, polyacrylic acid, Kaolin, polysorbate 80, propylene glycol, tartaric acid, PVP, titanium dioxide, water, CMC, mineral oil, petrolatum,
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 Temporary relief from minor aches and paons of sore muscles and joints
Purpose
Information about the drug product’s indications for use.Purpose s Topical Analgestic
Spl product data elements
Usually a list of ingredients in a drug product.AUVON Pain Relief menthol DIHYDROXYALUMINUM AMINOACETATE ANHYDROUS CARBOXYMETHYLCELLULOSE GLYCERIN METHYLPARABEN SODIUM POLYACRYLATE (2500000 MW) POLYSORBATE 80 PROPYLENE GLYCOL TARTARIC ACID TITANIUM DIOXIDE WATER PROPYLPARABEN KAOLIN POLYACRYLIC ACID (250000 MW) PETROLATUM MINERAL OIL MENTHOL MENTHOL
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.image description
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.MENTHOL AUVON Pain Relief Patch Drug Facts
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 If you are allergic to the listed ingredients If you are pregnent or breast feeding If you are under 12 years of age On wounds, cuts, damaged/broken/irritated skin On eyes or mucous membranes With heating pads/devices or wrap with a bandage With other topical analgesics If the package arrives damaged or opened.
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 and pets. If ingested, get medical help or contact a Poison Control Center right away.
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 You are experiencing pain, swelling or blistering Redness is persent or irritation develops Symptoms persist for more than 7 days or 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 this product ■ Use only as directed ■ Read and follow all directions and warnings on this label
Storage and handling
Information about safe storage and handling of the drug product.Storage Avoid storing patches in direct sunlight Protect patches from excessive moisture
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 Do not use If you are allergic to the listed ingredients If you are pregnent or breast feeding If you are under 12 years of age On wounds, cuts, damaged/broken/irritated skin On eyes or mucous membranes With heating pads/devices or wrap with a bandage With other topical analgesics If the package arrives damaged or opened. When using this product ■ Use only as directed ■ Read and follow all directions and warnings on this label Stop use and ask a doctor if You are experiencing pain, swelling or blistering Redness is persent or irritation develops Symptoms persist for more than 7 days or clear up and occur again within a few days Keep out of reach of children and pets. If ingested, 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