Tobcharm
FDA Label NDC 83462-002

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Eubizrival Llc for the product Tobcharm (NDC 83462-002). 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 ingredients, purpose, uses, warnings, directions, other information, inactive ingredients, product label, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Active Ingredients

Undecylenic Acid 10%

Purpose

Anti-Fungal

Uses

Hinder fungal and bacterial growth, reduce itching, cleanse skin tissue.

Warnings

For external use only

Do not use

  • on irritated skin and any area that is infected or reddened 
  • if pregnant or if there is any allergic reaction to this product.
  • When using this product

    • avoid contact with eyes.
    • Stop use and ask a doctor if

      • if discomfort persists
      • Keep out of reach of children.

        • if product get into eyes, flush with water for 15 minutes 
        • if swallowed, get medical help or contact a Poison Control Center right away.

Directions

  • Wash feet thoroughly with warm water, and gently file thickened part of the fungal nail with a nail file until its flat
  • apply layer of the liquid to the surface of the fungal nail and allow it to be absorbed into the nail. 
  • after the liquid has been absorbed, apply a layer of the cream to the infected parts of the nail 
  • repeat the process if necessary once a day  

Other Information

Store at room temperature and our of direact sunlight. Skin discoloration may occur during or after use.

Inactive Ingredients

mineral oil, apricot kernel oil, tea tree oil, tocopherol, peppermint oil, camphor oil, jojoba oil, bergamot oil, lavender oil

Product Label

Image Description (Image 1)

Image Description (Image 1)

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