SPL v2
SPL
SPL Set ID 2fe747ea-ab35-4ca8-e054-00144ff8d46c
Route
TOPICAL
Published
Effective Date 2016-04-07
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Clotrimazole (10 mg)
Inactive Ingredients
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

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2016-04-14

Description

Fungistat topical antifungal spray.

Purpose

Antifungal


Medication Information

Purpose

Antifungal

Description

Fungistat topical antifungal spray.

Section 51945-4

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

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.
  • 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.
Drug Facts

Fungistat topical antifungal spray.

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 & 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


Structured Label Content

Section 51945-4 (51945-4)

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

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.
  • 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.
Drug Facts

Fungistat topical antifungal spray.

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 & 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


Advanced Ingredient Data


Raw Label Data

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