Drug Factsactive Ingredient
Undecylenic Acid 20%
Nu Calmar
FDA Label NDC 73464-001
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Nu Calmar Pty Ltd for the product Nu Calmar (NDC 73464-001). 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 drug factsactive ingredient, purpose, uses:, warning:, directions:, inactive ingredients:, principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Anti-fungal
Uses:
Cures most Athlete's Foot, Jock Itch or Ringworm. For effective relief of itching, scaling, burning, redness, irritation, chafing associated with jock itch and itchy scaly skin between the toes.
Warning:
For external use only. Do not use on children under 2 years of age unless directed by a doctor. Avoid contact with the eyes. If irritation occurs or if there is no improvement within 2 weeks, discontinue use and consult a doctor.
Directions:
Wash the affected area and dry thoroughly. Apply a thin layer of the product over affected area twice daily (morning and night), or as directed by a doctor. 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 4 weeks. For jock itch, use daily for 2 weeks. If condition persists longer, consult a doctor. This product is not effective on the scalp or nails.
Inactive Ingredients:
Shea butter, Coconut Oil, Lemon Oil, Jojoba wax, Tocopherol, Grape Seed Oil, Zinc Oxide.
Principal Display Panel
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