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Drug Facts
Manufactured for: SprainGo, LLC
3802 Spectrum Blvd, Suite 112E
Tampa, FL 33612
Made in the USA
Relieveit Footspray
FDA Label NDC 58133-956
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Cosmetic Specialty Labs, Inc. for the product Relieveit Footspray (NDC 58133-956). 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 other, active ingredient, purpose, uses, warnings, otc - pregnancy or breast feeding, otc - keep out of reach of children, directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Active Ingredient
Menthol 8.0%
Purpose
External analgesic
Uses
For temporary relief of minor aches and pains of muscles, joints and feet.
Warnings
for external use only
When using this product: use only as directed• avoid contact with eyes or mucous membrane• do not apply to open wounds, damaged or very sensitive skin • Do not use if you are allergic to any of this product's Active or Inactive ingredients
Otc - Pregnancy Or Breast Feeding
If pregnant or breast-feeding, ask a health professional before use.
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.
Directions
• Spray balls of feet. arches, heels, toes and legs on bare skin before starting your day or activity:
6 - 8 sprays each foot· Apply generously when wearing stockings; 8+ sprays each foot
• Let dry completely • Apply again as needed for extended relief
Children under 2: consult a doctor before use
• Spray balls of feet. arches, heels, toes and legs on bare skin before starting your day or activity:
6 - 8 sprays each foot· Apply generously when wearing stockings; 8+ sprays each foot
• Let dry completely • Apply again as needed for extended relief
Children under 2: consult a doctor before use
Inactive Ingredients
Arnica Montona, Cyclomethicone, Ethyl Alcohol. Ethoxydiglycol. Eucalyptus Oil. Horpogophytum. lsopropyl Palmitate, Lemon Oil, Lemongrass Oil, Pinus Resin, Propylene Glycol, Peppermint Oil, Teo Tree Oil, Wintergreen Oil
Other Information
• Do not use if the package seal is broken• Store at 68-77°F (20 -25°)
• Keep this package. It contains important information on directions for use
* Please review the disclaimer below.
