Active Ingredients
Menthol USP 3%
Re-leve Footlube Pain Relief
FDA Label NDC 61577-5042
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Sombra Cosmetics Inc. for the product Re-leve Footlube Pain Relief (NDC 61577-5042). 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, keep out of the reach of children, uses, warnings, directions, inactive ingredients, questions or comments?, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Purpose
External Analgesic
Keep Out Of The Reach Of Children
Keep out of the reach of children
Uses
Detoxifies joints, relieves sore feet, athletes foot, foot odor, perspiration and coldness. Soothes and relieves pain after long hours of standing on feet.
Warnings
Keep out of the reach of children. For external use only. Aviod contact with eyes and mucous membranes, wounds or damaged skin. Store at room temperature. Do not use with heating pads. If symtoms do not respond within one week, see doctor. ReLEVE Products makes no medical claims.
Directions
Apply before putting on socks and shoes.
Inactive Ingredients
Purified water, Carbomer, Yellow #5 Colorant, Blue #1 Colorant, Hamamelis Viriniana Leaf Extract, Yucca Schidigera Stem/Root Extract, Citrus Grandis (Grapefruit) Seed Extract, Decyl Glucoside, Vegetable Glycerin, Aloe Barbadensis Leaf Juice, Emu Oil, Simmondsia Chinensis (Jojoba) Seed oil, Phenoxyethanol, Germanium oil, Caprylyl Glycol, Sodium Carbonate.
Questions Or Comments?
Call Toll Free: 1-866-673-5383, 6070 S. Eastern Ave. Suite 210, Las Vegas, NV 89119, www.reskincare.com
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