Pinceladas Para Hongos Navarro
FDA Label NDC 53145-119

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 Pinceladas Para Hongos Navarro (NDC 53145-119). 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 active ingredient, purpose, uses, warnings, do not use, stop use and ask doctor if, if pregnant or breast-feeding,, keep out of reach of children., and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient

Undecylenic Acid 20%.................Antifungal

Purpose

Antifungal

Uses

  • For the treatment of most athelete's foot, jock itch and ringworm
  • For relief if itching, scaling, cracking, burning, redness, soreness, irritations, discomfort, chafing associated with jock itch
  • For the relief of itch, scaly skin between toes
  • Clears up most athelete's foot infection and with daily use helps keep it from comming back

Warnings

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

Stop Use And Ask Doctor If

  • For athelete's foot and ringworm, irritation occurs or if there is no improvement within 4 weeks.
  • For jock itch, if irritation occurs or if there is no improvement within 2 weeks.

If Pregnant Or Breast-Feeding,

ask health professional before use. 

Keep Out Of Reach Of Children.

In case of accidental ingestion, get medical help or contact a Poison Control Center right away.

Directions

Clean 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 use of this product. For athelete'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 athelete'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.

Other Information

  • Protect from freezing. If freezing occurs, warm to room temperature 70°-80° F.
  • TAMPER EVIDENT DISCLOSURE: Do not use if seal is torn, broken or missing.

Inactive Ingredients

  • isopropyl alcohol 99%, water

* Please review the disclaimer below.