Active Ingredients:
Clotrimazole 1.00%
Smooth Gator Fungus Eliminator Liquid
FDA Label NDC 70673-747
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Smooth Gator, Llc for the product Smooth Gator Fungus Eliminator (NDC 70673-747). 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 active ingredients:, purpose:, uses:, warnings:, ask a doctor before use, when using this product, stop use and ask doctor if, keep out of rich of children., and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose:
Antifungal Treatment
Uses:
For the cure of most • athlete’s foot (tinea pedis) • ringworm (tinea corporis) • jock itch (tinea cruris)
For relief of • itching • scaling • cracking • burning • redness • soreness • irritation • discomforts which may accompany these conditions.
Warnings:
- For external use only.
Ask A Doctor Before Use
- on children under 2 years of age.
When Using This Product
- avoid contact with eyes.
Stop Use And Ask Doctor If
Irritation occurs or there is no improvement within 4 weeks (2 weeks for jock itch).
Keep Out Of Rich Of Children.
If swallowed, get medical help or contact a Poison Control Center immediately
Directions:
Read all package directions and warnings before using.
• Use only as directed.
• Clean the affected area with soap and warm water and dry thoroughly.
• Apply a thin layer over the affected area twice daily (morning and night) or as directed by a doctor.
• Avoid applying to severely cracked or irritated areas.
• For athlete’s foot: pay special attention to spaces between toes, wear well-fitting, ventilated shoes, and change shoes and socks at least once daily.
• For athlete’s foot and ringworm, use daily for 4 weeks; for jock itch, use daily for 2 weeks.
• Supervise children in the use of this product.
• Intended for use by normally healthy adults only.
• Persons under 18 years of age or those with sensitive or allergic skin should use only as directed by a doctor.
Other Information:
Apply to skin around affected areas. While not all finger and toe fungal infections are curable with OTC topical medications, if you see improvement within 4 weeks of use, you may continue to use until satisfactory results are obtained.
Inactive Ingredients:
BHT, Carthamus Tinctorius (Safflower) Oil, Emu Oil, Eucalyptus Globulus(Eucalyptus) Oil, Glycine Soja (Soybean) Oil, Helianthus Annuus (Sunflower) Oil, Lavandula Angustifolia (Lavender) Oil, Malaleuca Alternifolia (Tea Tree) Oil, Mentha Piperita (Peppermint) Oil, Olea Europaea (Olive) Oil, Prunus Amygdalus Dulcis (Sweet Almond) Oil, Tocopheryl Acetate (Vitamin E).
Package Labeling:
Label (Label)
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