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| Product NDC Code | 68788-8064 | ||||
|---|---|---|---|---|---|
| Drug Name | Methyl salicylate |
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| Type | Generic | ||||
| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | PATCH | ||||
| RxCUI drug identifier | 1053397 | ||||
| Application Number | part348 | ||||
| Labeler Name | Preferred Pharmaceuticals Inc. | ||||
| Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredient
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 18 years of age and older: Apply 1 patch to the affected area of intact skin up to 3 times a day. Do not leave patch on for more than 8 hours at a time. - Clean and dry the affected area. - Open pouch and remove one patch. - Remove any protective film and apply directly to affected area of pain. Apply immediately after removal from the protective envelope. - Wash hands with soap and water after handling the patches. - Reseal pouch containing unused patches after each use. Do not store patch outside the sealed envelope. - Fold used patches so that the adhesive side sticks to itself and safely discard used patches or pieces of cut patches where children and pets cannot get to them. Children under 18 years: Ask a physician
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients Polysorbate 80, Glycerin, Sodium Cellulose Glycolate, Sodium Polyacrylate, Vitamin E, EDTA Disodium Salt, Kaolin, Water, Methylparaben Methyl Salicylate 10% Patch NDC: 50488-2010-1 10 Patches Manufactured for: Alexso, Inc Los Angeles, CA 90064 Relabeled by: Preferred Pharmaceuticals Inc.
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, such as simple backache, lumbago, arthritis, neuralgia, strains, bruises, and sprains.
Purpose
Information about the drug product’s indications for use.Purpose Methyl Salicylate 10% …………………………..…………………….….…Topical analgesic
Spl product data elements
Usually a list of ingredients in a drug product.Methyl Salicylate Methyl Salicylate METHYL SALICYLATE SALICYLIC ACID POLYSORBATE 80 GLYCERIN CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED .ALPHA.-TOCOPHEROL EDETATE DISODIUM KAOLIN WATER METHYLPARABEN SODIUM POLYACRYLATE (8000 MW)
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 Methyl Salicylate 10% Patch Topical Analgesic NDC 68788-8064 10 Patches Methyl Salicylate 10% Patch
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
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. Consult physician for children under 18.
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 • Avoid contact with the eyes • You may experience a burning sensation. The intensity of this reaction varies among individuals and may be severe. 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.Other information • May be applied under occlusive dressing. • Store at 20-25°C (68-77°F); excursions permitted to 15-30°C (59-86°F). See USP Controlled Room Temperature.
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. Use only as directed or as directed by a health care professional. Read all warnings and directions before use. Discontinue use at least one hour prior to bath, shower, or swimming; do not use immediately after bath, shower, or swimming. 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. Consult physician for children under 18. When using this product • Avoid contact with the eyes • You may experience a burning sensation. The intensity of this reaction varies among individuals and may be severe. 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 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
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