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Product NDC Code | 72562-103 | ||||
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Drug Name | Tommie copper pain relief maximum strength |
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Type | Brand | ||||
Active Ingredients |
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Route | TOPICAL | ||||
Dosage Form | CREAM | ||||
RxCUI drug identifier | 313518 | ||||
Application Number | part348 | ||||
Labeler Name | Tommie Copper, Inc. | ||||
Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Trolamine Salicylate 10%
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.For the temporary relief of minor aches and pain associated with simple backache, arthritis, strains, bruises, and sprains.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Aloe Barbadensis (Aloe Vera) Leaf Extract, Arnica Montana (Arnica) Flower Extract, Calendula Officinalis (Marigold) Flower Extract, Camellia Sinensis (Green Tea) Leaf Extract, Cetyl Alcohol, Chamomilla Recutita (Matricaria) Flower Extract, Echinacea Angustifolia (Coneflower) Extract, Glycerin, Ilex Paraguariensis (Yerba Mate) Leaf Extract, Juniperus Communis (Juniper) Fruit Extract, Methylparaben, Mineral Oil, Potassium Phosphate, Propylparaben, Stearic Acid, Triethanolamine, Water.
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.Adults and children 12 years of age : apply generously to the affected area, massage into painful area until thoroughly absorbed into the skin, repeat as necessary, but not more than 3 to 4 times daily. Children under 12 years of age : ask a doctor.
Purpose
Information about the drug product’s indications for use.Topical Analgesic.
Spl product data elements
Usually a list of ingredients in a drug product.Tommie Copper Pain Relief Maximum Strength Trolamine Salicylate 10% CALENDULA OFFICINALIS FLOWER ILEX PARAGUARIENSIS LEAF JUNIPER BERRY CHAMOMILE ECHINACEA ANGUSTIFOLIA STEARIC ACID CETYL ALCOHOL WATER GLYCERIN TROLAMINE METHYLPARABEN MINERAL OIL POTASSIUM PHOSPHATE, MONOBASIC PROPYLPARABEN TROLAMINE SALICYLATE SALICYLIC ACID ALOE VERA LEAF GREEN TEA LEAF ARNICA MONTANA FLOWER
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.Label
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.
Pregnancy or breast feeding
Pregnancy or Breast feedingIf pregnant or breast-feeding , ask a health care professional before use.
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.For external use only . Allergy Alert: if prone to allergic reaction from aspirin or salicylates, consult a doctor before use. When using this product use only as directed, avoid taking a bath or shower within 1 hour before or after applying, do not bandage or use with a heating pad, avoid contact with eyes or mucous membranes, do not apply to wounds or damaged skin. Stop use and ask a doctor if condition worsens or symptoms persist for more than 7 days, if symptoms clear up and occur again within a few days.
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