FDA Label for Tripenicol C
View Indications, Usage & Precautions
Tripenicol C Product Label
The following document was submitted to the FDA by the labeler of this product Trifluent Pharma Llc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Other
DRUG FACTS
Active Ingredient
Undecylenic Acid 13%
Purpose
Antifungal
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.
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.
Otc - Keep Out Of Reach Of Children
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.
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 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
Other Information
Store in dry area at 20-25°C (68-77°F)
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
* Please review the disclaimer below.