Hongocura Pinceladas Liquid
FDA Label NDC 53145-019

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 Pinceladas (NDC 53145-019). 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 a doctor if, if pregnant or breast-feeding, keep out of the reach of children., and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Active Ingredient

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

Purpose

Anti-Fungal

Uses

  • for the treatment of most athlete’s foot (tinea pedis), jock itch (tinea curis) and ringworm (tinea corporis)
  • 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

Warnings

For external use only . Avoid contact with the eyes.

Flammable: Keep away from fire and flames.

Do Not Use

  • on children under 2 years of age, unless directed by a docyor
  • for diaper rash

Stop Use And Ask A Doctor If

for athlete's foot and ringworm: irritation occurs or if there is no improvement within 4 weeks.

ZFor jock itch: If irritation occurs or if there is no improvement within two weeks.

If Pregnant Or Breast-Feeding

ask a health professional before use 

Keep Out Of The Reach Of Children.

In case of accidental ingestion, get medical help  or contact a Poiso 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 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 th e scalp or nails

Othe Information

  • protect from freezing, If freezing occurs, warm to room tewmperature 70°-80° F
  • Tamper Evident Disclosure: Do not use if safety seal is torn, broken or missing.

Inactive Ingredients

isopropyl alcohol and water.

* Please review the disclaimer below.