Flexitol Medicated Foot
FDA Label NDC 43251-3340

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Lacorium Health International Pty Ltd for the product Flexitol Medicated Foot (NDC 43251-3340). 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 other, active ingredient, purpose, uses, otc - do not use, 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

→ Other

→ Active Ingredient

→ Purpose

→ Uses

→ Otc - Do Not Use

→ Otc - When Using

→ Otc - Stop Use

→ Otc - Keep Out Of Reach Of Children

→ Directions

→ Other Information

→ Inactive Ingredients

→ Questions Or Comments?

→ Principal Display Panel - 56 G Tube Carton

Other

Drug Facts

USA DISTRIBUTOR:
LaCorium Health USA Inc.,
Boca Raton, Florida 33487

MANUFACTURED FOR:
LaCorium Health International Pty Ltd.,
Level 14, Tower 2,
101 Grafton Street,
Bondi Junction NSW 2022, Australia

Active Ingredient

Tolnaftate 1%

Purpose

Antifungal

Uses

Clinically proven to prevent Athlete's Foot (Tinea Pedis) and Ringworm (Tinea Corporis) with daily use
For effective relief of symptoms of Athlete's Foot, including itching, burning, cracking, scaling and discomfort associated with this condition.

Otc - Do Not Use

Do not use on children under 2 years of age unless directed by a doctor

Otc - When Using

For External Use Only
Avoid contact with eyes

Otc - Stop Use

If irritation occurs or if there is no improvement within 4 weeks (for Athlete's Foot) discontinue use and consult a doctor

Otc - Keep Out Of Reach Of Children

Do not use if seal on tube is punctured or is not visible. Keep out of reach of children.

Directions

Clean the affected area and dry thoroughly
Apply a thin layer of the product over the affected area twice daily (morning and night), or as directed by a doctor
Supervise children in the use of this product
For Athlete's Foot: pay special attention to the spaces between the toes; wear well fitting, ventilated shoes and change shoes and socks at least once daily.
Use daily for 4 weeks. If condition persists longer consult a doctor.
To prevent Athlete's Foot, apply once or twice daily (morning and/or night)
This product is not effective on the scalp or nails
Replace cap and tighten after each use.

Other Information

Store between 50°- 86°F in a dry place

Inactive Ingredients

Aloe, Benzalkonium Chloride, Cetearyl Alcohol, Ceteth-20, Cetyl Alcohol, Glycerin, Lavandula, Angustifolia (Lavender) Oil, Menthol, Mineral Oil, Petrolatum, Polysorbate 60, Propylene Glycol, Sodium Phosphate, Tocopherol, Urea, Water