Drug Facts

Drug Facts
SPL v2
SPL
SPL Set ID 6d50530a-7d56-454e-a205-4111cb687840
Route
TOPICAL
Published
Effective Date 2012-05-24
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Clotrimazole (1 g)
Inactive Ingredients
Aloe Vera Leaf Cetearyl Ethylhexanoate Dimethicone Edetate Disodium Glycerin Methylparaben Phenoxyethanol Polysorbate 20 Propylene Glycol Propylparaben Stearic Acid Alpha-tocopherol Acetate Trolamine Urea Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2012-06-15
Description

Active Ingredient Clotrimazole 1%

Medication Information

Warnings and Precautions
Warnings ■ Do not use under children 2 years of age unless directed by a doctor ■ For external use only ■ Avoid spraying into the eyes ■ Do not use on deep wounds, infections or lacerations ■ Supervise children in the use of this product
Indications and Usage
Use Footlogix Intensive Diabetic Formula: - with Dermal Infusion Technology for the cure and prevention of fungal infections associated with Athlete’s foot fungus. This Anti-fungal, intensivecare formulation provides effective relief of itching, scaling, cracking, burning, redness and irritation of the skin. Natural skin functions remain unhindered.

Dosage and Administration
Directions ■ Clean the affected area and dry thoroughly ■ Hold the can upright ■ Shake well before each use ■ Use sparingly twice daily for the first two weeks and continue once daily until the problem is corrected  ■ When used as directed, this can contains enough mousse for approximately two months supply ■ If condition persists, consult a doctor
Description

Active Ingredient Clotrimazole 1%

Section 42229-5

Caution : ■  Contents are under pressure ■  Protect from direct sunlight and do not store at temperatures above 120F/50C ■  After use, do not puncture or incinerate container ■  Spray only in a well ventilated area ■  Do not spray in presence of open flame or spark or while smoking

Section 50565-1

Keep out of reach of children to avoid accidental poisoning. In case of accidental ingestion, contact a doctor or Poison Control Center immediately

Section 50569-3

Stop use and ask a doctor if : ■ irritation occurs or if there is no improvement within 4 weeks ■ there are deep puncture wounds, infections or lacerations

Section 51727-6

I n active Ingredients Aloe Barbadensis Leaf Juice, Cetearyl Ethylhexanoate, Dimethicone, Disodium EDTA, Glycerin, Methylparaben, Phenoxyethanol, Polysorbate 20, Propylene Glycol, Propylparaben, PVP, Stearic Acid, Tocopheryl Acetate, Triethanolamine, Ubiquinone, Urea, Water.

Section 51945-4
Package Label



Section 55105-1
Purpose

Antifungal
Section 55106-9
Active Ingredient

Clotrimazole 1%

Structured Label Content

Indications and Usage (34067-9)
Use Footlogix Intensive Diabetic Formula: - with Dermal Infusion Technology for the cure and prevention of fungal infections associated with Athlete’s foot fungus. This Anti-fungal, intensivecare formulation provides effective relief of itching, scaling, cracking, burning, redness and irritation of the skin. Natural skin functions remain unhindered.

Dosage and Administration (34068-7)
Directions ■ Clean the affected area and dry thoroughly ■ Hold the can upright ■ Shake well before each use ■ Use sparingly twice daily for the first two weeks and continue once daily until the problem is corrected  ■ When used as directed, this can contains enough mousse for approximately two months supply ■ If condition persists, consult a doctor
Warnings and Precautions (34071-1)
Warnings ■ Do not use under children 2 years of age unless directed by a doctor ■ For external use only ■ Avoid spraying into the eyes ■ Do not use on deep wounds, infections or lacerations ■ Supervise children in the use of this product
Section 42229-5 (42229-5)

Caution : ■  Contents are under pressure ■  Protect from direct sunlight and do not store at temperatures above 120F/50C ■  After use, do not puncture or incinerate container ■  Spray only in a well ventilated area ■  Do not spray in presence of open flame or spark or while smoking

Section 50565-1 (50565-1)

Keep out of reach of children to avoid accidental poisoning. In case of accidental ingestion, contact a doctor or Poison Control Center immediately

Section 50569-3 (50569-3)

Stop use and ask a doctor if : ■ irritation occurs or if there is no improvement within 4 weeks ■ there are deep puncture wounds, infections or lacerations

Section 51727-6 (51727-6)

I n active Ingredients Aloe Barbadensis Leaf Juice, Cetearyl Ethylhexanoate, Dimethicone, Disodium EDTA, Glycerin, Methylparaben, Phenoxyethanol, Polysorbate 20, Propylene Glycol, Propylparaben, PVP, Stearic Acid, Tocopheryl Acetate, Triethanolamine, Ubiquinone, Urea, Water.

Section 51945-4 (51945-4)
Package Label



Section 55105-1 (55105-1)
Purpose

Antifungal
Section 55106-9 (55106-9)
Active Ingredient

Clotrimazole 1%

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:55:29.193317 · Updated: 2026-03-14T22:53:10.919261