Botanimedix Onychorx Antifungal Nail Gel
FDA Label NDC 52261-5800

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Cosco International, Inc. for the product Botanimedix Onychorx Antifungal Nail Gel (NDC 52261-5800). 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 drug facts, uses:, indications & usage, directions:, warnings:, otc - when using, otc - stop use, otc - 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

Drug Facts

Active Ingredient Purpose
Undecylenic Acid 25%........................Anti-fungal

Uses:

For the cure of most Tinea Pedis (athlete's foot) and Tinea Corporis (ringworm)

Indications & Usage

For relief of:

Itching, Burning, Redness, Irratation, Scaling, Soreness
Discomfort which may accompany these conditions

Directions:

Apply twice daily for best results.

Warnings:

For external use only.

Otc - When Using

When using this product

  • Do not get into eyes.

Otc - Stop Use

Stop use and ask a doctor if:

  • Condition worsens.
  • Symptoms last more than 7 days or clear and occur again within a few days.

Otc - 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.

Inactive Ingredients:

Alpha Tocopheryl Acetate (Vitamin E), Cannabidiol, Cetostearyl Alchohol, Clove Leaf Oil, Dimethyl Sulfoxide, Ethylhexylglycerin, Eucalyptus Oil, Glyceryl Monostearate, Hypromellose, Isopropyl Palmitate, Peppermint Oil, Phenoxyethanol, Polysorbate 60, Propolis Wax, Tea Tree Oil, Urea, Water

Questions?

Call: 1-800-964-5406

www.botanimedix.com

Distributed By:

BotaniMedix

Atlanta, GA 30067

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