SPL v1
SPL
SPL Set ID 2fc20e9c-c95a-6a41-e054-00144ff8d46c
Route
TOPICAL
Published
Effective Date 2016-04-05
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Clotrimazole (10 mg)
Inactive Ingredients
Water Polysorbate 80 Arnica Montana Undecylenic Acid Peppermint Oil Salicylic Acid Sodium Propionate Sodium Lauryl Sulfate Sorbic Acid Propionic Acid Thymol Aloe Vera Leaf Isopropyl Alcohol Methyl Ethyl Ketone

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2016-04-12

Description

Fungistat topical antifungal liquid.

Purpose

Antifungal


Medication Information

Purpose

Antifungal

Description

Fungistat topical antifungal liquid.

Section 51945-4

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

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.
Drug Facts

Fungistat topical antifungal liquid.

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.
Active Ingredient

Clotrimazole 1.0%

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


Structured Label Content

Section 51945-4 (51945-4)

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

Purpose

Antifungal

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.
Drug Facts

Fungistat topical antifungal liquid.

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.
Active Ingredient

Clotrimazole 1.0%

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 (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


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