Active Ingredient
Tolnaftate 1%
Tolnaftate Antifungal Powder
FDA Label NDC 71335-2249
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Bryant Ranch Prepack for the product Tolnaftate Antifungal (NDC 71335-2249). 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, keep out of reach of children, directions, other information, inactive ingredients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
ANTIFUNGAL
Uses
• for effective treatment of most athlete’s foot (tinea pedis)
and ringworm (tinea corporis)
• for effective relief of itchy, scaly skin between the toes
• clears up most athlete’s foot infection and with daily
use helps keep it from coming back
Warnings
For external use only
Do not use on children under 2 years of age unless
directed by a doctor.
When using this product avoid contact with the eyes
Stop use and consult a doctor if
• irritation occurs
• there is no improvement within 4 weeks
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
• use daily for 4 weeks. If condition persists longer,
consult a doctor.
For athlete's foot
• pay special attention to the spaces between the toes
• wear well-fitting ventilated shoes
• change shoes and socks at least once daily
• to prevent athlete’s foot, clean and dry feet thoroughly.
Apply as above once or twice daily.
This product is not effective on the scalp or nails.
Other Information
• store at room temperature
Inactive Ingredients
corn starch and talc
How Supplied
NDC: 71335-2249-1: 45 g in a BOTTLE
Package Label.Principal Display Panel
Tolnaftate 1% Powder #45
Label (Lbl713352249)
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