Active Ingredient
Tolnaftate 1 %
Anti-fungal
FDA Label NDC 53807-123
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Rij Pharmaceutical Corporation for the product Anti-fungal (NDC 53807-123). 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, warnings, keep out of reach of children., directions, other information, inactive ingredients, package label display, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Antifungal
Warnings
For external use only
Do not use on children under 2 years of age.
When using this product avoid contact with the eyes
Stop use and ask a doctor if
- irritation occurs
- there is no improvement within 4 weeks (for athlete's foot) or within 2 weeks (for jock itch)
Keep Out Of Reach Of Children.
If swallowed, get medical help or contact a Poison Control Center right away.
Directions
- shake well before use
- clean the affected area and dry thoroughly
- apply a thin layer of the product over affected area twice daily (morning and night) or as directed by a doctor
- supervise children in the use of this product
- this product is not effective on the scalp or nails
- use daily for 4 weeks
- pay special attention to the spaces between the toes
- wear well-fitting, ventilated shoes
- change shoes and socks at least once a daily
- to prevent athlete's foot: clean and dry feet thoroughly, apply once or twice daily
- use daily for 2 weeks
For athletes foot
For jock itch
Other Information
store between 2° - 30° C (36° - 86° F)
Inactive Ingredients
starch, talc
Package Label Display
Anti-fungal Powder Label (Antifungal Powder)
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