FUNGISTAT MAX- clotrimazole liquid

Drug Details [pdf]

Drug Facts

Fungistat topical antifungal spray.
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.
- 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
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

INGREDIENTS AND APPEARANCE

FUNGISTAT MAX
clotrimazole liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 37945-910
Route of Administration	TOPICAL

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

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

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC: 37945-910-45	1 in 1 BOX	04/14/2016
1	NDC: 37945-910-44	118 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part333C	04/14/2016

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

Name	Address	ID/FEI	Business Operations
Establishment
Bio-Medical & Pharmaceutical Manufacturing Corporation		072186356	manufacture(37945-910)

FUNGISTAT MAX- clotrimazole liquid

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Drug Labeling and Warnings

Drug Details [pdf]