Drug Facts
Fungistat topical antifungal spray.
Fungistat Max
FDA Label NDC 37945-910
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Bio-medical & Pharmaceutical Manufacturing Corporation for the product Fungistat Max (NDC 37945-910). 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 drug facts, active ingredient, purpose, indications, warnings, directions, inactive ingredients, questions & comments, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Active Ingredient
Clotrimazole 1.0%
Purpose
Antifungal
Indications
- Cures most tinea pedis (athlete's foot), tinea cruris (jock itch), and tinea corporis (ringworm).
- Relieves itching, burning feet and itching, scaling, cracking, burning, redness, soreness, irritation, discomfort, and chafing associated with jock itch.
- Clears up most athlete’s foot infection and with daily use helps keep it from coming back.
Warnings
- Do not use on children under 2 years of age unless directed by a doctor.
- For external use only.
- Avoid contact with the eyes.
- For Athlete’s Foot: If irritation occurs or if there is no improvement within 4 weeks, discontinue use and consult a doctor.
- For Jock Itch: If irritation occurs or if there is no improvement within 2 weeks, discontinue use and consult a doctor.
- Do not use for diaper rash.
- Flammable – Do not use near open flame or heat source.
Directions
- Wash the affected area and dry thoroughly.
- Spray a thin layer of the product over affected area twice daily (morning and night) or as directed by a doctor.
- Allow product to dry before covering.
- Supervise children in the use of this product.
- For Athlete’s Foot: Pay special attention to the spaces between the toes; wear well-fitting, ventilated shoes, and changes shoes and socks at least once daily.
- For Athlete’s Foot & Ringworm: Use daily for 4 weeks.
- For Jock Itch: Use daily for 2 weeks.
- For Jock Itch: Some discomfort upon application is normal and should fade as product dries. Do not cover until dry.
- If condition persists longer, consult a doctor.
- This product is not effective on the scalp or nails.
Inactive Ingredients
Water, Isopropyl Alcohol, Polysorbate 80, Arnica Montana, Methyl Ethyl Ketone, Sodium Lauryl Sulfate, Undecylenic Acid, Peppermint Oil, Salicylic Acid, Sodium Propionate, Sorbic Acid, Propionic Acid, Thymol, Aloe Vera Leaf.
Questions & Comments
Bio-Medical & Pharmaceutical Manufacturing Corporation
4311 South Dr., Houston, TX 77053-4820
Phone: 281.835.8051 M-F 8am-5pm
Internet: www.kleerplex.com
Package Label.Principal Display Panel
Professional Fungistat Max
1% Clotrimazole Athlete's Foot Care
Maximum Strength OTC Spray
Cures Most Athlete's Foot, Jock Itch & Ringworm In 2 Weeks
NDC 37945-910-44
Contains 4 fl. oz
Fungistat Max (Kleer Plex Pro 4 Oz Fungistat Max Athletes Foot Spray Label 160407)
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