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| Product NDC Code | 50488-1016 | ||||
|---|---|---|---|---|---|
| Drug Name | Methyl salicylate 25 percent |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | CREAM | ||||
| RxCUI drug identifier | 238542 | ||||
| Application Number | M017 | ||||
| Labeler Name | Alexso, Inc | ||||
| Packages |
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| Check if available Online | Get Medication Prices online with Discount |
Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredient Methyl Salicylate 25%
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 2 years and older apply externally to the affected area up to 3 to 4 times a day children under 2 years ask a doctor
| adults and children 2 years and older | apply externally to the affected area up to 3 to 4 times a day |
| children under 2 years | ask a doctor |
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients Aqua (Deionized Water), Arnica Montana Flower Extract, Indian Frankincense, Chondroitin Sulfate, Ethylhexylglycerin, Glucosamine Sulfate, Glycerin, Glyceryl Monostearate, Cetostearyl Alcohol, Aloe Vera Leaf, C13-14 Isoparaffin, Isostearyl Palmitate, Trolamine, Laureth-7, PEG-100 Stearate, Phenoxyethanol, Propylene Glycol, Stearic Acid. Methyl Salicylate 25% Pump Bottle Cream NDC: 50488-1016-5 50 mL Manufactured for: Alexso, Inc Los Angeles, CA 90064 Tel: 888.495.6078
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 Topical analgesic
Spl product data elements
Usually a list of ingredients in a drug product.Methyl Salicylate 25 Percent Methyl Salicylate METHYL SALICYLATE SALICYLIC ACID WATER ARNICA MONTANA FLOWER INDIAN FRANKINCENSE CHONDROITIN SULFATE (BOVINE) ETHYLHEXYLGLYCERIN GLUCOSAMINE SULFATE GLYCERYL MONOSTEARATE CETOSTEARYL ALCOHOL ALOE VERA LEAF C13-14 ISOPARAFFIN ISOSTEARYL PALMITATE TROLAMINE LAURETH-7 PEG-100 STEARATE PHENOXYETHANOL PROPYLENE GLYCOL STEARIC 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 50488-1016-5 Methyl Salicylate 25% Pump Bottle Cream 50 mL Rev 05/24 NDC 50488-1016-5 Methyl Salicylate 25% Pump Bottle Cream 50 mL Rev 05/24
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.Methyl Salicylate 25 % Pump Bottle Cream 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. If swallowed, 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 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 Do not use in large quantities, particularly over raw surfaces or blistered areas Do not apply to wounds or damaged skin Do not bandage
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. When using this product Avoid contact with the eyes Do not use in large quantities, particularly over raw surfaces or blistered areas Do not apply to wounds or damaged skin Do not bandage 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 Keep out of reach of children. If swallowed, 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