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| Product NDC Code | 73352-555 | ||||
|---|---|---|---|---|---|
| Drug Name | Tripenicol c |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | CREAM | ||||
| RxCUI drug identifier | 1250978, 2677085 |
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| Application Number | M005 | ||||
| Labeler Name | Trifluent Pharma LLC | ||||
| Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.ACTIVE INGREDIENT Undecylenic Acid 13%
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 Wash the affected area with soap and water and dry thoroughly. Apply a thin layer of the product over affected area twice daily (morning and night), or as directed by a physician. Supervise children in the use of this product. For Athlete's Foot, pay special attention to spaces between the toes; wear well-fitting, ventilated shoes and change shoes and socks at least once daily. For Athlete's Foot and Ringworm, use daily for four (4) weeks; for Jock Itch, use daily for two (2) weeks. If condition persists longer, consult a physician. This product is not effective on the scalp or nails. Wash hands after each use.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.INACTIVE INGREDIENTS Aloe barbadensis (Aloe Vera) Leaf Juice, Caprylic/Capric Triglyceride, Cetyl Alcohol, Clotrimazole, Disodium EDTA Dihydrate, Glyceryl Stearate, Hydrogenated Polydecene, Hydroxyethylcellulose, Lavandula angustifolia (Lavender) Oil, Melaleuca alternifolia (Tea Tree) Oil, Methylparaben, PEG-100 Stearate, Polysorbate 60, Propylparaben, Purified Water, Sodium Polyacrylate, Stearic Acid, Trideceth-6, Triethanolamine, Urea
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 Cures most Athlete's Foot (Tinea Pedis), Jock Itch (Tinea Cruris), and Ringworm (Tinea Corporis). Relives discomfort, itching, cracking, burning and scaling, which accompany these conditions.
Purpose
Information about the drug product’s indications for use.PURPOSE Antifungal
Spl product data elements
Usually a list of ingredients in a drug product.Tripenicol C Undecylenic Acid UNDECYLENIC ACID UNDECYLENIC ACID WATER HYDROXYETHYL CELLULOSE, UNSPECIFIED ALOE VERA LEAF EDETATE DISODIUM UREA MEDIUM-CHAIN TRIGLYCERIDES POLYSORBATE 60 PEG-100 STEARATE CETYL ALCOHOL GLYCERYL MONOSTEARATE STEARIC ACID METHYLPARABEN PROPYLPARABEN TROLAMINE CLOTRIMAZOLE LAVENDER OIL TEA TREE OIL SODIUM POLYACRYLATE (8000 MW) HYDROGENATED POLYDECENE (1500 CST) TRIDECETH-6
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 - 37.0 mL Bottle Label TRIFLUENT PHARMA ® TRIPENICOL™ C ANTIFUNGAL CREAM UNDECYLENIC ACID NDC 73352-555-01 1.25 FL OZ (37.0 mL) PRODUCT SHOULD BE ADMINISTERED UNDER THE SUPERVISION OF A LICENSED MEDICAL PRACTITIONER PRINCIPAL DISPLAY PANEL - 37.0 mL Bottle 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
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 this and all drugs out of reach of children. In case of accidental ingestion, seek professional assistance or contact poison control center immediately (800)-222-1222.
Storage and handling
Information about safe storage and handling of the drug product.OTHER INFORMATION Store in dry area at 20-25°C (68-77°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.WARNING Do not use on children under two years of age unless directed by a physician. For external use only. Avoid contact with eyes. If irritation occurs or if there is no improvement within four (4) weeks (for Athlete's Foot or Ringworm) or within two (2) weeks (for Jock Itch), discontinue use and consult a physician. Keep this and all drugs out of reach of children. In case of accidental ingestion, seek professional assistance or contact poison control center immediately (800)-222-1222.
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