Forticept Antifungal Balm
FDA Label NDC 52261-0100

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Cosco International, Inc. for the product Forticept Antifungal Balm (NDC 52261-0100). 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, otc - do not use section, otc - when using section, indications & usage section, otc - keep out of reach of children section, directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

→ Active Ingredient/purpose

→ Uses

→ Warnings

→ Otc - Do Not Use Section

→ Otc - When Using Section

→ Indications & Usage Section

→ Otc - Keep Out Of Reach Of Children Section

→ Directions

→ Other

→ inactive Ingredients:

→ 30g

→ 60g

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 FORTICEPT^TM 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