Active Ingredeints Purpose
Lidocaine HCI 4% Topical Anesthetic
Shoe Pain Relief Spray
FDA Label NDC 87288-001
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Sole Amie for the product Shoe Pain Relief (NDC 87288-001). 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 ingredeints purpose, uses, directions, warning for external use only, keep out of reach children, inactive ingredients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Uses
For temporary relief of foot pain associated with fatigue, minor cuts, minor scrapes, minor skin irritations
Directions
For adult use: apply a thin layer to your feet before wearing shoes, and as needed. Do not use more than 3 to 4 times daily
Warning For External Use Only
Flamable:keep away fom fire or flame
When using this product: avoid spraying in eyes; contents under pressure; do not puncture or incinerate; do not store at temperature above 120F
Stop use and ask doctor if: condition worsens, or if symptoms persist for more than 7 days, or clear up and reossu again withing few days
Keep Out Of Reach Children
If swallowed, get medical help, or contact a Poison Control center right away
Inactive Ingredients
Acrylates/C10-30 Alkyl Acrylate Crosspolymer
Alcohol Denat
Aloe Barbadensis Leaf
Benzoic Acid
C12-15 Alkyl Benzoate
Chamomilla Recutita (Matricaria) Flower Extract
Dimethylpolysiloxane
Dimethyl Siloxane reaction with silica
Disodium EDTA
Ethylhexylglycerin
Glycerin
Glycerides, C14-18, mono and di
Glycerol
Lavandula Angustifolia (Lavender) Oil
Methylparaben
Octamethylcycloetrasiloxane
1,2- Propanediol, 3-(4-chiorophenoxy)
Phenoxyethanol
Polyethylene Glycol
Propylene Glycol
Polyethylene Glycol Stearate
Tocopheryl Acetate
Triethanolamine
Water
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