Tripenicol C Cream
FDA Label NDC 73352-555

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Trifluent Pharma Llc for the product Tripenicol C (NDC 73352-555). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding other, active ingredient, purpose, uses, warning, otc - keep out of reach of children, directions, inactive ingredients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

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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

Principal Display Panel (37.0 mL Bottle Label)

Principal Display Panel (37.0 mL Bottle Label)

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