Neomen Antifungal Pen Liquid
FDA Label NDC 88017-001

12 label sections · Submitted to the FDA by Heartland Cloud Llc · Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Heartland Cloud Llc for the product Neomen Antifungal Pen (NDC 88017-001). 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 active ingredient, purpose, uses, warnings, do not use, when using this product, stop use and ask a doctor if, 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 25%

Purpose

Antifungal

Uses

  • for the treatment of most athlete's foot, jock itch and ringworm

Warnings

For external use only

Do Not Use

on children under 2 years of age

When Using This Product

avoid contact with the eyes

Stop Use And Ask A Doctor If

  • irritation occurs
  • there is no improvement within 4 weeks for athlete's foot or ringworm; or there is no improvement within 2 weeks for jock itch

Keep Out Of Reach Of Children

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

  • wash the affected area and dry thoroughly
  • apply a thin layer over affected area twice daily (morning and night)
  • 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, ask a doctor
  • this product is not effective on the scalp or nails

Inactive Ingredients

1,2-Hexanediol, Acacia Senegal Gum, Alcohol, Borneol, Butylene Glycol, Camellia Sinensis Leaf Extract, Centella Asiatica Extract, Chamomilla Recutita (Matricaria) Flower Extract, Chlorphenesin, Disodium EDTA, Fragrance, Glycerin, Glycyrrhiza Glabra (Licorice) Root Extract, PEG-40 Hydrogenated Castor Oil, Phenoxyethanol, Polygonum Cuspidatum Root Extract, Propylene Glycol, Rosmarinus Officinalis (Rosemary) Leaf Extract, Scutellaria Baicalensis Root Extract, Water

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