Fungi Nail Everyday Antifungal Powder Spray
FDA Label NDC 55505-234
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Kramer Laboratories for the product Fungi Nail Everyday Antifungal Powder (NDC 55505-234). 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 otc - active ingredient, otc - purpose, indications & usage, warnings, otc - do not use, otc - when using, otc - stop use, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
| Active Ingredient | Purpose |
| Tolnaftate 1% | Anti-fungal |
Indications & Usage
Use helps prevent most athlete's foot with daily use.
Warnings
For external use only.
Otc - Do Not Use
Flammable: Do not use while smoking or near heat or flame. Do not puncture or incinerate. Contents under pressure. Do not store above 120°F. Intentional misuse by deliberately concentrating and inhaling contents can be harmul or fatal.
Otc - When Using
Do not use on children under 2 years of age unless directed by a doctor.
Otc - Stop Use
When using this product
■ avoid contact with eyes
■ use only as directed.
Stop use and ask a doctor if irritation occurs.
Otc - Keep Out Of Reach Of Children
KEE OUT OF REACH OF CHILDREN. If swallowed, get medical help or contact a Poison Control Center right away.
Dosage & Administration
Directions
■ To prevent athlete's foot, wash and dry feet thoroughly
■ Shake can well and spray a thin layer of the product to the feet once or twice daily (morning and/or night)
■ Supervise children in the use of this product.
■ Pay special attention to spaces between the toes; wear well-fitting, ventilated shoes, and change shoes and socks at least once daily
■ In case of clogging, clean nozzle with pin.
Storage And Handling
Other information store between 20° to 25°C (68° to 77°F)
Inactive Ingredient
Inactive ingredients Butylated Hydroxytoluene, Isobutane, Kaolin, PPG-12 Buteth-16, SD Alcohol 40B (14% w/w), Zea Mays (Corn Starch)
Principal Display Panel
NEW MAXIMUM STRENGTH
FUNGI
NAIL®
TOLNAFTATE ANTI-FUNGAL
EVERYDAY
TOE & FOOT ANTI-FUNGAL
POWDER SPRAY
STOPS
FOOT FUNGUS
BEFORE IT
CAN SPREAD
Use Daily To Prevent
Most Athlete's Foot
▪ Absorbs Wetness
To Fight Odor
▪ Talc-free
NET WT 4.6 OZ (130 g)
Not for nail or scalp fungus.
For more information about
Fungi-Nail® and money back
guarantee, visit us at funginail.com
Dist. by: Kramer Laboratories, Inc.
Bridgewater, NJ 08807
1-800-824-4894
K0524
Spray (Fungi Nail Spray)
Can (Fungi Nail Can)
* Please review the disclaimer below.
