FDA Label for Flexitol Anti Fungal
View Indications, Usage & Precautions
Flexitol Anti Fungal Product Label
The following document was submitted to the FDA by the labeler of this product Lacorium Health International Pty Ltd. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
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
Comments Or Questions?
Call Toll Free 1-866-478-3338
[email protected]
www.flexitol.com
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)
* Please review the disclaimer below.