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| Product NDC Code | 82165-102 | ||||
|---|---|---|---|---|---|
| Drug Name | Topical analgesic |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | OINTMENT | ||||
| RxCUI drug identifier | 2569962 | ||||
| Application Number | part348 | ||||
| Labeler Name | Dermaline USA Corp | ||||
| Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active Ingredient(s) Methyl Salicylate 5% Purpose: Topical Analgesic Dermaline Label
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 Apply to affected area not more than 3 to 4 times daily.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients Arnica, Camphor, D&C Brown #486, Menthol, Mineral Oil, Paraffin Wax, Propylparaben, White Petrolatum.
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 temporary relief minor aches and pains of muscles and joints associated with simple backache, arthritis, strains, bruises and sprains.
Purpose
Information about the drug product’s indications for use.Purpose Topical Analgesic, Ointment
Spl product data elements
Usually a list of ingredients in a drug product.Topical Analgesic Dermaline Arnica Salve Black PARAFFIN ARNICA MONTANA CAMPHOR (SYNTHETIC) WHITE PETROLATUM METHYL SALICYLATE SALICYLIC ACID MENTHOL MINERAL OIL PROPYLPARABEN
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 2.5oz Label Display
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 Do not Use on children under 16 years of age except on the advice of a physician.
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. In case accedental ingestion, 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 condition worsens, or if symptoms persist for more than 7 days or 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.Adults and children 16 years of age and older: Wash the affected area with mild soap and warm water and rinse thoroughly. Apply to affected area not more than 3 to 4 times daily. Do not bandage tightly or apply to wounds or damaged skin. Children under 16 years of age consult a doctor.
Storage and handling
Information about safe storage and handling of the drug product.Other information Store at controlled room temperature 15-30C (59-86F) Do not expose to excessive heat
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. Avoid contact with the eyes. Do not bandage tightly or apply to wounds or damaged skin.
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