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| Product NDC Code | 79643-003 | ||||
|---|---|---|---|---|---|
| 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 | M017 | ||||
| Labeler Name | PHARMACURE LLC | ||||
| Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active Ingredient Purpose Methyl Salicylate 10% (NSAID: Nonsteroidal anti-inflammatory drug) Topical Analgesic
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 18 years and older: • Clean and dry affected area • Only use one patch at a time • Remove patch from backing film and apply to skin • Apply one patch to the affected area and leave in place for up to 8 to 12 hours • If pain lasts after using the first patch, a second patch may be applied for up to another 8 to 12 hours • Do not use more than 2 patches per day • Do not use for more than 3 days in a row • The used patch should be removed from the skin when a new one is applied • Children under 18 years of age: do not use: this product has not been shown to work in children
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients Adhesive, myrrh gum, zinc oxide.
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 Temporarily relieves mild to moderate aches & pains of muscles & joints associated with: • strains • sprains • simple backache • arthritis • bruises
Spl product data elements
Usually a list of ingredients in a drug product.Methyl Salicylate Methyl Salicylate MYRRH ZINC OXIDE METHYL SALICYLATE SALICYLIC ACID
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.Product label image description
Storage and handling
Information about safe storage and handling of the drug product.Other information • Store at 20-25°C (68-77°F) • Avoid storing product in direct sunlight •Protect product from excessive moisture •Some individuals may not experience pain relief until several hours after applying the patch
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 Stomach bleeding warning : This product contains an NSAID, which may cause stomach bleeding. The chance is small but higher if you: • are age 60 or older • have had stomach ulcers or bleeding problems • take a blood thinning (anticoagulant) or steroid drug • take other drugs containing an NSAID (aspirin, ibuprofen, naproxen, or others] • have 3 or more alcoholic drinks every day while using this product • take more or for a longer time than directed Do not use • on the face or rashes • on wounds or damaged skin • if allergic to aspirin or other NSAIDs • with a heating pad • when sweating (such as from exercise or heat) • any patch from a pouch that has been open for 14 or more days • right before or after heart surgery Ask a doctor before use if • you are allergic to topical products • the stomach bleeding warning applies to you • you have high blood pressure, heart disease, or kidney disease • you are taking a diuretic When using this product • wash hands after applying or removing patch. Avoid contact with eyes. If eye contact occurs, rinse thoroughly with water. • the risk of heart attack or stroke may increase if you use more than directed or for longer than directed Stop use and ask a doctor if • stomach pain or upset gets worse or lasts • you feel faint, vomit blood, or have bloody or black stools These are signs of stomach bleeding. • rash, itching or skin irritation develops • condition worsens • symptoms last for more than 3 days • symptoms clear up and occur again within a few days If pregnant or breast-feeding, ask a doctor before use while breast-feeding and during the first 6 months of pregnancy. Do not use during the last 3 months of pregnancy because it may cause problems in the unborn child or complications during delivery. Keep out of reach of children. If put in mouth, get medical help or contact a Poison Control Center right away. Package not child resistant. Dispose of the used patches after folding sticky ends together.
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