Drug Facts
Fungistat topical antifungal liquid.
Fungistat Max
FDA Label NDC 37945-908
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 37945-908). 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 or 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.
- Apply a thin layer of the product over affected area twice daily (morning and night) or as directed by a doctor.
- The brush applicator allows easy application under the nails and surrounding cuticle area.
- Always use well-ventilated shoes and change socks at least once each day.
- 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.
- 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 Or Comments
Bio-Medical & Pharmaceutical Mfg. Corp.
4311 South Dr.
Houston, TX 77053-4820
Phone: 281.835.8051 M-F 8am-5pm
Internet: www.kleerplex.com
Package Label.Principal Display Panel
Kleer-Plex
PROFESSIONAL FUNGISTAT MAX
1% Clotrimazole Transdermal Liquid
NDC 37945-908-13
Contains 1 fl. oz.
Cures Fungal Infections Fast
Maximum Strenth OTC Liquid
Safe & Effective Prescription Alternative
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