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| Product NDC Code | 73352-575 | ||||
|---|---|---|---|---|---|
| Drug Name | Tricylate |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | CREAM | ||||
| RxCUI drug identifier | 311503, 2685260 |
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| Application Number | M017 | ||||
| Labeler Name | Trifluent Pharma LLC | ||||
| 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 ingredients Purpose Menthol 2% Topical Analgesic Methyl Salicylate 10% Topical Analgesic
| Active ingredients | Purpose |
|---|---|
| Menthol 2% | Topical Analgesic |
| Methyl Salicylate 10% | 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 and children 2 years of age and older: Apply to affected area not more than 3 to 4 times daily. Children under 2 years of age: Do not use; consult a doctor.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients Alkyl (C12-15) benzoate, butylparaben, Carica papaya (papaya) fruit extract, Carthamus tinctorius (safflower) seed oil, cetyl alcohol, dimethicone, disodium EDTA, emulsifying wax, ethylparaben, glycerin, glycerol stearate, hydrogenated polydecene, hydroxyethyl cellulose, isobutylparaben, methylparaben, PEG 100 stearate, phenoxyethanol, propylene glycol, propylparaben, purified water, sodium lactate, sodium polyacrylate, trideceth-6, xanthan gum.
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 associated with simple backache, arthritis, strains, bruises, and sprains.
Purpose
Information about the drug product’s indications for use.Active ingredients Purpose Menthol 2% Topical Analgesic Methyl Salicylate 10% Topical Analgesic
| Active ingredients | Purpose |
|---|---|
| Menthol 2% | Topical Analgesic |
| Methyl Salicylate 10% | Topical Analgesic |
Spl product data elements
Usually a list of ingredients in a drug product.Tricylate MENTHOL, UNSPECIFIED FORM and Methyl Salicylate MENTHOL, UNSPECIFIED FORM MENTHOL, UNSPECIFIED FORM METHYL SALICYLATE SALICYLIC ACID ALKYL (C12-15) BENZOATE BUTYLPARABEN PAPAYA SAFFLOWER OIL CETYL ALCOHOL DIMETHICONE EDETATE DISODIUM ETHYLPARABEN GLYCERIN GLYCERYL MONOSTEARATE PEG-100 STEARATE HYDROGENATED POLYDECENE TYPE I HYDROXYETHYL CELLULOSE, UNSPECIFIED ISOBUTYLPARABEN METHYLPARABEN PHENOXYETHANOL PROPYLENE GLYCOL PROPYLPARABEN WATER SODIUM LACTATE SODIUM POLYACRYLATE (2500000 MW) TRIDECETH-6 XANTHAN GUM
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 - 85 G Pouch Tube Label Tear at notch to open. Do not use if seal is broken. NDC 73352-575-04 TRIFLUENT PHARMA™ Tricylate™ 2% Menthol 10% Methyl Salicylate Topical Analgesic Cream NET WT. 3 OZ. (85 G) PRINCIPAL DISPLAY PANEL - 85 G Pouch Tube Label
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
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 otherwise than as directed. Keep out of reach of children to avoid accidental poisoning. If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.
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 to avoid accidental poisoning. If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions/Comments? (210) 944-6920
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.When using this product Avoid contact with eyes. Do not apply to wounds or damaged skin. Do not bandage tightly.
Pregnancy or breast feeding
Pregnancy or Breast feedingIf pregnant or breastfeeding, ask a health professional before use.
Storage and handling
Information about safe storage and handling of the drug product.Other information Store at temperatures less than 30°C (86°F).
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 Do not use Do not use otherwise than as directed. Keep out of reach of children to avoid accidental poisoning. If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away. When using this product Avoid contact with eyes. Do not apply to wounds or damaged skin. Do not bandage tightly. 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. If pregnant or breastfeeding, ask a health professional before use.
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