Otc - Active Ingredient
Active Ingredients Purpose
Undecylenic Acid 5%...................Antifungal
Zinc Undecylenate 20%...............Antifungal
Hongocura Ointment
FDA Label NDC 53145-017
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Menper Distributors, Inc. for the product Hongocura (NDC 53145-017). 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 otc - active ingredient, otc - purpose, indications & usage, warnings, otc - keep out of reach of children, otc - pregnancy or breast feeding, dosage & administration, inactive ingredient, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Purpose Antifungal
Indications & Usage
Uses:
Proven effective in the treatment of athlete's foot (tinea pedis),jock itch (tinea cruris) and ringworm (tinea corporis).
For the effective relief of itching, burning, crackling and scaly skin between toes.
Clears up athlete's foot infection and with daily use, helps keep it from coming back.
Warnings
Warning: for external use only- Avoid contact with the eyes
Do not use:
On children under 2 years of age, unless directed by a doctor. For diaper rash. This product is not effective on the scalp or nails.
Stop use and ask a doctor if: For athlete's foot and ringworm, if irritation occurs or if there is no improvement within 4 weeks. For jock itch, if irritation occurs or if there is no improvment within 2 weeks
Otc - Keep Out Of Reach Of Children
Keep away of reach of children. In case of accidental ingestion, get medical help or contact a Posion Control Center, right away.
Otc - Pregnancy Or Breast Feeding
If pregnant or breast-feeding, ask a health professional before use.
Dosage & Administration
Directions:
Clean the affected area and dry throughly. Apply a thin layer of the product over affected area twice daily (morning and night) or as directed by a doctor. Supervise children in 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 for the scalp or nails.
Inactive Ingredient
Inactive ingredients: Methylparaben, propylparaben and white petrolatum
Otc - Questions
Questions? www.menperdistributors.com or 1-800-560-5223, M-F 9 am- 4 pm EST
Package Label.Principal Display Panel
Hongocura Ointment (Hongocuraointment)
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