KLEER-PLEX FUNGISTAT FUNGUS CURE- clotrimazole liquid liquid 
Bio-Medical & Pharmaceutical Manufacturing Corporation

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.

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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,eppermint Oil, Salicylic Acid,Sodium Propionate, Sorbic Acid, Propionic Acid,Thymol, Aloe Vera Leaf.

Questions & 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

fungistat

KLEER--PLEX®

Fungistat

Fungus Cure

NDC 37945-906-12

1 fl. oz.

Maximum-Strength Liquid

Eliminates Toe & Foot

Fungal Infections Fast

KLEER-PLEX FUNGISTAT FUNGUS CURE 
clotrimazole liquid liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37945-906
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CLOTRIMAZOLE (UNII: G07GZ97H65) (CLOTRIMAZOLE - UNII:G07GZ97H65) CLOTRIMAZOLE10 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
PEPPERMINT OIL (UNII: AV092KU4JH)  
SALICYLIC ACID (UNII: O414PZ4LPZ)  
ISOPROPYL ALCOHOL (UNII: ND2M416302)  
ARNICA MONTANA (UNII: O80TY208ZW)  
METHYL ETHYL KETONE (UNII: 6PT9KLV9IO)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
UNDECYLENIC ACID (UNII: K3D86KJ24N)  
SODIUM PROPIONATE (UNII: DK6Y9P42IN)  
SORBIC ACID (UNII: X045WJ989B)  
PROPIONIC ACID (UNII: JHU490RVYR)  
THYMOL (UNII: 3J50XA376E)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:37945-906-131 in 1 BOX09/29/201502/24/2017
1NDC:37945-906-1229.6 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333C09/29/201502/24/2017
Labeler - Bio-Medical & Pharmaceutical Manufacturing Corporation (072186356)
Establishment
NameAddressID/FEIBusiness Operations
Bio-Medical & Pharmaceutical Manufacturing Corporation072186356manufacture(37945-906)

Revised: 3/2017
 
Bio-Medical & Pharmaceutical Manufacturing Corporation