FDA Label for Forticept Antifungal Balm
View Indications, Usage & Precautions
Forticept Antifungal Balm Product Label
The following document was submitted to the FDA by the labeler of this product Cosco International, Inc.. 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.
Active Ingredient/Purpose
Tolnaftate 1% w/w........................Antifungal
Uses
Proven clinically effective in the treatment and prevention of most athlete's foot (tinea pedis), ringworm (tinea corporis), and jock itch (tinea cruris).
Warnings
For external use only
Otc - Do Not Use Section
Do not use on children under 2 years of age unless direceted by a doctor.
Otc - When Using Section
When using this product avoid contact with eyes.
Indications & Usage Section
Stop use and ask a doctor if irritation occurs or there is no improvement within 4 weeks (for athlete's foot or ringworm) or 2 weeks (for jock itch).
Otc - Keep Out Of Reach Of Children Section
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Directions
- Read all package directions and warnings before use. Use only as directed.
- Clean the affected area with soap and warm water and dry thoroughly.
- Apply a thin layer of FORTICEPTTM COOLING BALM over the affected area twice daily (morning and night), or as directed by a doctor.
- 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 individuals 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
Other Information store between 20° - 25°C (68° - 77°F)
Inactive Ingredients:
Acticire®, Capric Caprylic Triglyceride, Dimethicone, Eucalyptus Oil, Glyceryl Behenate, Glyceryl Stearate, Lavender Oil, LexFeel® N5, Methyl Lactate, PEG 40 Hydrogenated Castor Oil, Polyhexanide, Sunflower Oil, Tea Tree Oil, Water
30G
60G
* Please review the disclaimer below.