Otc - Active Ingredient
Active Ingredient
Dimethicone 1%
Footlogix
FDA Label NDC 42479-214
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 (NDC 42479-214). 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
Purpose
Skin Protectant
Indications & Usage
Uses: Footlogix Moisturizing Diabetic Formula- with Dermal Infusion Technology is an effective daily maintenance formula that hydrates and relieves the extremely dry, cracked skin of the feet. This unique fragrance-free, lightweight mousse formula also softens, protects the skni and prevents damage due to dryness by replenishing the skin's moisture barrier.
Warnings
Warnings ■ Do not use on 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, Butylene Glycol, Cetearyl Ethylhexanoate, Disodium EDTA, Glycerin, Isostearic Acid, Methylparaben, Phenoxyethanol, Polysorbate 20, Propylene Glycol, Propylparaben, PVP, SD Alcohol 40-B, Sorbitol, Spirulina Platensis Extract, Stearic Acid, Tocopheryl Acetate, Triethanolamine, Ubiquinone, Urea, Water.
Package Label.Principal Display Panel
Product Label
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