Otc - Active Ingredient
Active ingredient
Tolnaftate 1%
Lavinso Athlete Foot Spray
FDA Label NDC 87011-101
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Lavinso Trading Llc for the product Lavinso Athlete Foot (NDC 87011-101). 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 - do not use, otc - when using, otc - stop use, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Purpose
Antifungal
Indications & Usage
Uses
• Cures most athlete’s foot (tinea pedis) and jock itch (tinea cruris)
• Helps prevent most athlete’s foot with daily use
• Relieves itching, burning, cracking and scaling associated with these conditions
Warnings
Warnings
For external use only
Otc - Do Not Use
Do not use
• On children under 2 years of age unless directed by a doctor
Otc - When Using
When using this product
• Avoid contact with eyes
• Use only as directed
Otc - Stop Use
Stop use and ask a doctor if
• Irritation occurs
• There is no improvement within 4 weeks (athlete’s foot) or 2 weeks (jock itch)
Otc - Keep Out Of Reach Of Children
Keep out of reach of children.
If swallowed, get medical help or contact a Poison Control Center right away.
Instructions For Use
Directions
• Clean and dry the affected area
• Shake well before use. Spray a thin layer twice daily (morning and night)
• For athlete’s foot, pay special attention to spaces between the toes
• Use daily for 4 weeks for athlete’s foot; 2 weeks for jock itch
• To help prevent athlete’s foot, apply once daily
• Keep feet dry; change socks daily. Supervise children in use
• Not effective on scalp or nails
Storage And Handling
Other information
• Store at 59–86 °F (15–30 °C)
• Safety sealed: do not use if shrink-band around cap is broken or missing
Inactive Ingredient
Inactive ingredients
Aloe Barbadensis Leaf Juice, Citric Acid, Denatured Alcohol 40-B, Ethylhexylglycerin, Eucalyptus Globulus Leaf Oil, Lavender Oil, Menthol, PEG-40 Hydrogenated Castor Oil, Peppermint Oil, Phenoxyethanol, Propylene Glycol, Purified Water, Sodium Citrate, Tea Tree Leaf Oil.
Otc - Questions
Questions?
Email us at [email protected] or visit lavinso.com
When Using This Product
• Avoid contact with eyes
• Use only as directed
Package Label.Principal Display Panel
ATHLETE’S FOOT
ANTIFUNGAL SPRAY
Tolnaftate 1%
Cures & prevents most athlete’s foot
Fast-dry, cooling botanical formula
118 ML / 4.0 FL OZ
Designed in USA
Distributed by
Lavinso Trading LLC
300 Sunny Isles Blvd, Unit 1204
Sunny Isles Beach, FL 33160 USA
Made in India
NDC 87011-101
Batch No
Exp Date
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