Otc - Active Ingredient
Active IngredientClotrimazole 1%
Footlogix Intensive Care
FDA Label NDC 42479-213
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Kvg Group Inc for the product Footlogix Intensive Care (NDC 42479-213). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding otc - active ingredient, otc - purpose, indications & usage, warnings, otc - ask doctor, otc - keep out of reach of children, dosage & administration, other, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
PurposeAntifungal
Indications & 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.
Warnings
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
Otc - Ask Doctor
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
Otc - Keep Out Of Reach Of Children
Keep out of reach of children to avoid accidental poisoning. In case of accidental ingestion, contact a doctor or Poison Control Center immediately
Dosage & 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
Other
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
Inactive Ingredient
Inactive 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.
Package Label.Principal Display Panel
Package Label
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