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Fungistat Max by Bio-Medical & Pharmaceutical Manufacturing Corporation

Medically reviewed on April 9, 2018

Dosage form: liquid
Ingredients: CLOTRIMAZOLE 10mg in 1mL
Labeler: Bio-Medical & Pharmaceutical Manufacturing Corporation
NDC Code: 37945-910

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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

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 
clotrimazole liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37945-910
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CLOTRIMAZOLE (CLOTRIMAZOLE) CLOTRIMAZOLE10 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
ALOE VERA LEAF 
PEPPERMINT OIL 
SODIUM PROPIONATE 
SORBIC ACID 
PROPIONIC ACID 
WATER 
ARNICA MONTANA 
SODIUM LAURYL SULFATE 
SALICYLIC ACID 
THYMOL 
ISOPROPYL ALCOHOL 
POLYSORBATE 80 
METHYL ETHYL KETONE 
UNDECYLENIC ACID 
Packaging
#Item CodePackage Description
1NDC:37945-910-451 BOTTLE, SPRAY in 1 BOX
1NDC:37945-910-44118 mL in 1 BOTTLE, SPRAY
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333C04/14/2016
Labeler - Bio-Medical & Pharmaceutical Manufacturing Corporation (072186356)
Establishment
NameAddressID/FEIOperations
Bio-Medical & Pharmaceutical Manufacturing Corporation072186356manufacture(37945-910)

 
Bio-Medical & Pharmaceutical Manufacturing Corporation

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Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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