Flexitol Anti Fungal
FDA Label NDC 43251-3351

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 Anti Fungal (NDC 43251-3351). 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, warnings, otc - do not use, otc - when using, 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

Drug Facts

Active Ingredient

Undecylenic Acid 25%

Purpose

Antifungal

Uses

For the treatment of: most Athlete's Foot (Tinea Pedis), Ringworm (Tinea Corporis). For relief of: itching, scaling, cracking, burning, redness, soreness, irritation and discomfort which may accompany these conditions.

Warnings

  • For external use only

Otc - Do Not Use

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

Otc - When Using

  • Extremely flammable
  • Keep away from fire or flame
  • Avoid smoking during use and until product has dried

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

Otc - Stop Use

  • Discontinue use and consult a doctor if irritation occurs or there is no improvement within 4 weeks

Directions

  • Read all directions and warnings before use
  • Clean affected area with soap and warm water and dry thoroughly
  • Apply a thin layer of Flexitol Anti-Fungal Liquid over the affected area twice daily (morning and night) or as directed by a doctor
  • 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.
  • For Athlete's Foot and Ringworm use daily for 4 weeks. If condition persists longer, consult a doctor.
  • Persons under 18 years of age or those with sensitive skin should use only as directed by a doctor
  • Supervise children in the use of this product
  • 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 Barbadensis Leaf Juice, Butylated Hydroxytoluebe, Eucalyptus Globulus Oil, Hydroxypropyl Methylcellulose, Isopropyl Alcohol, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Tocopherol Acetate, Urea, Water

Principal Display Panel - 30Ml Bottle Carton

Flexitol®

Anti-Fungal
Liquid

Treats Fungus

APPROVED
AMERICAN
PODIATRIC
MEDICAL
ASSOCIATION

Clinically Proven

Easy brush-on APPLICATOR

WITH UREA, ALOE VERA, VITAMIN E,
TEA TREE & EUCALYPTUS OILS

NDC: 43251-3351

1 fl oz (30ml)

Principal Display Panel (30ml Bottle Carton)

Principal Display Panel (30ml Bottle Carton)

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