Pedesil
FDA Label NDC 24909-301

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Aidance Skincare & Topical Solutions, Llc for the product Pedesil (NDC 24909-301). 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, keep out of reach of children., otc - stop use, directions, other information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient

Clotrimazole 1%

Purpose

Antifungal

Uses

  • Cures finger and toe area fungal infections.
    • For effective relief of itching, scaling, cracking, burning, discoloration, soreness, irritation, discomfort and chafing associated with fungal infection.


Warnings

For external use only. Do not use on children under 2 years of age unless directed by a doctor. When using this product avoid contact with eyes.

Keep Out Of Reach Of Children.

If swallowed, call poison control or seek medical help.

Otc - Stop Use

Stop and use and ask a doctor if irritation occurs or there is no improvement within 4 weeks.

Directions

  • For nail care, wash and dry affected skin. Apply a thin layer of Pedesil around and under entire nail and cuticle twice daily (morning and night) or as directed by a doctor.
    • If you see improvement within 4 weeks of use, you may continue use until satisfactory results are obtained.
      • For athlete's foot, pay special attention to spaces between 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.
        • If condition persists longer, consult a doctor. Intended for use by normally healthy adults only. Persons under 18 years of age or those with highly sensitive or allergic skin should use only as directed by a doctor. Supervise children in the use of this product.

Other Information

Store at room temperature.

Other Ingredients

Beeswax, Bentonite, Eucalyptus Citriodora Oil, Jojoba Seed Oil, Magnesium Oxide, Silver Oxide, Tea Tree Oil,
Zinc Oxide.

Otc - Questions

Questions? 877-4-AIDANCE

Principal Display Panel - 28G Carton

Carton Image (Pedesil Box Max 5 2 12)

Carton Image (Pedesil Box Max 5 2 12)

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