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| Product NDC Code | 82944-101 | ||||
|---|---|---|---|---|---|
| Drug Name | Methyl salicylate 10% |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | PATCH | ||||
| RxCUI drug identifier | 1053397 | ||||
| Application Number | 505G(a)(3) | ||||
| Labeler Name | ION PHARMA, LLC | ||||
| Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredients: Methyl Salicylate 10% (NSAID: nonsteroidal anti-inflammatory drug)
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 10 years of age and older: only use one patch at a time clean and dry affected area remove patch from backing film and apply to skin (see illustration) apply 1 patch to the affective area of intact skin up to 36 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
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients Hypoallergenic Acrylic Adhesive
Questions or comments? 833.711.8833 [email protected]
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 aches & pains of muscles & joints associated with: Strains Sprains Simple Backache Arthritis Bruises
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.Methyl Salicylate 10% Methyl Salicylate ACRYLIC ACID 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.PRINCIPAL DISPLAY PANEL NDC 82944-101-10 METHYL SALICYLATE 10% Topical Analgesic (NSAID) TOPICAL PAIN PATCH For Temporary Pain Relief Flexible Patch Innovation Soothing and Effective Long Lasting Relief WATER RESISTANT TECHNOLOGY Qty: 10 Flexible Patches (5 Per Resealable Pouch) x2 3 x 5 (7.62cm x 12.7cm) APPLY FOR 36 HOURS ION PHARMA MADE IN USA methyl salicylate jpg
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.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 heat surgery
Ask a doctor before use if you are allergic to topical products the stomach bleeding warning applies to you you are taking a diuretic you have high blood pressure, heart disease or kidney disease
Keep out of reach of children. if put in mouth, get medical help or contact a Poison Control right away. Package not child resistant. Dispose of the used patches after folding sticky ends together.
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 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.
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 wash hands after applying or removing patch. Avoid contact with eyes. If eye contact occurs, rinse thoroughly with the water. the risk of heart attack or stroke may increase if you use more than directed or for longer than directed.
Pregnancy or breast feeding
Pregnancy or Breast feedingIf 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.
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 as NSAID (aspirin, ibuprofen, naproxen, or others) have 3 or more alcoholic drinks every day while using this product 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 heat surgery Ask a doctor before use if you are allergic to topical products the stomach bleeding warning applies to you you are taking a diuretic you have high blood pressure, heart disease or kidney disease When using this product wash hands after applying or removing patch. Avoid contact with eyes. If eye contact occurs, rinse thoroughly with the 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 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