FUNGISTAT MAX- clotrimazole transdermal liquid liquid

Fungistat Max by

Drug Labeling and Warnings

Fungistat Max by is a Otc medication manufactured, distributed, or labeled by Bio-Medical & Pharmaceutical Manufacturing Corporation. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Fungistat topical antifungal liquid.

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.

Keep Out Of Reach Of Children

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

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

INGREDIENTS AND APPEARANCE

FUNGISTAT MAX 
clotrimazole transdermal liquid liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 37945-908
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CLOTRIMAZOLE (UNII: G07GZ97H65) (CLOTRIMAZOLE - UNII:G07GZ97H65)	CLOTRIMAZOLE	10 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
ARNICA MONTANA (UNII: O80TY208ZW)
UNDECYLENIC ACID (UNII: K3D86KJ24N)
PEPPERMINT OIL (UNII: AV092KU4JH)
SALICYLIC ACID (UNII: O414PZ4LPZ)
SODIUM PROPIONATE (UNII: DK6Y9P42IN)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
SORBIC ACID (UNII: X045WJ989B)
PROPIONIC ACID (UNII: JHU490RVYR)
THYMOL (UNII: 3J50XA376E)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
ISOPROPYL ALCOHOL (UNII: ND2M416302)
METHYL ETHYL KETONE (UNII: 6PT9KLV9IO)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 37945-908-12	1 in 1 BOX	04/12/2016
1	NDC: 37945-908-13	30 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333C	04/12/2016

Labeler - Bio-Medical & Pharmaceutical Manufacturing Corporation (072186356)

Establishment
Name	Address	ID/FEI	Business Operations
Bio-Medical & Pharmaceutical Manufacturing Corporation		072186356	manufacture(37945-908)