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Product NDC Code | 83569-003 | ||||
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Drug Name | Rapid relief hot relief patch |
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Type | Brand | ||||
Active Ingredients |
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Route | TOPICAL | ||||
Dosage Form | PATCH | ||||
RxCUI drug identifier | 1053397 | ||||
Application Number | M017 | ||||
Labeler Name | RAPID AID VIET NAM CO., LTD | ||||
Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active Ingredient(s) Methyl Salicylate 10% w/w.
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 For use by adults and children 12 years of age and older: Open resealable pouch and remove patch If desired, cut patch to size Peel off protective film and apply sticky side to desired area Apply patch to affected area not more than 3 to 4 times daily and for no longer than 1-2 hours per application Remove patch before applying a new one Dispose of patch in waste receptacle after use
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients castor oil, dihydroxyaluminum aminoacetate, edetate disodium, gelatin, glycerine, menthol. Polyacrylic acid, polysorbate 80, polyvinyl alcohol, sodium carboxymethyl cellulose, sodium polyacrylate, 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 the temporary relief of minor aches and pains of muscles and joints associated with backache, lumbago, strains, buries, sprains and arthritis or rheumatic pain, or pain of tendons and ligaments.
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.Rapid Relief Hot Relief Patch Methyl Salicylate Methyl Salicylate SALICYLIC ACID menthol castor oil gelatin tartaric acid Polysorbate 80 POLYVINYL ALCOHOL, UNSPECIFIED POLYACRYLIC ACID (450000 MW) glycerin water edetate disodium SODIUM POLYACRYLATE (8000 MW) dihydroxyaluminum aminoacetate CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED
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.Package Label - Principal Display Panel image description
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, cuts, damaged or infected skin On eyes, mouth, genitals, or any other mucous membranes
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 Children 12 years of age and under: should only use this product upon the advice of a healthcare practitioner.
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: Allergic reaction occurs Condition worsens or does not improve within 7 days Symptoms clear up and return within a few days Redness, irritation, swelling, pain or other symptoms begin or increase
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: You may experience a burning sensation. The intensity of this reaction varies among individuals and may be sever. With regular use, this sensation generally disappears after several days. Avoid contact with the eyes, lips, nose and mucous membranes Do not tightly wrap or bandage the treated area Do not apply heat to the treated area immediately before or after use
Storage and handling
Information about safe storage and handling of the drug product.STORAGE AND HANDLING Store between 15-30℃(59-86℉) keep away from children
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 apply to sensitive skin or open wounds. Avoid contact with eyes or mucous membranes If excessive redness, burning or discomfort of the skin develop, discontinue use and consult a healthcare practitioner. 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 healthcare practitioner. Never use this product with any other heating or cooling device or with other external analgesic products. The application of external heat, such as an electric heating pad, may result in excessive skin irritation or burn. Do not bandage this product or cover with anything other than light clothing Do not use this product if you are allergic to salicylates or if you are taking anticoagulant medications.
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