Drug Facts
Topical Burn Cream plus Pain Relief
Burn Solution Cream
FDA Label NDC 70704-212
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Burn Solution Foundations for the product Burn Solution Cream (NDC 70704-212). 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 drug facts, active ingredient, purpose, indications, warnings, directions, other information, inactive ingredients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Active Ingredient
Tetracaine (1.0%).......................Pain & Itch Relief
Purpose
For temporary relief of minor aches and pains of muscles and joints commonly associated with backache, arthritis, strains, bruises, sprains, and burns
Indications
• For cooling, deep-penetrating pain relief, apply a thin layer sparingly to affected areas.
• Apply up to 3 times daily
Warnings
• Not for use on children under 2 years old except as directed by a doctor.
• Avoid contact with the eyes.
• For external use only.
• If irritation develops and persists, discontinue use and consult a doctor.
• If condition worsens or if symptoms persist for more than 7 days or clear up and occur again within a few days, discontinue use and consult a doctor.
Directions
• Apply this product topically to affected areas.
• Use up to 3 times daily.
• Use only as directed.
Other Information
External Anesthetic
Inactive Ingredients
Water, Stearic Acid, Lauramide DEA, Beeswax, Propylene Glycol, Sodium Tetraborate, Sodium Lauryl Sulfate, Diazolidinyl Urea,
Methylparaben, Propylparaben, Triethanolamine, Eucalyptus Oil.
Questions Or Comments
Burn Solution Foundation
Land O Lakes, FL
888.368.0555
http://relief-roller.com
Package Label.Principal Display Panel
starell
* Please review the disclaimer below.
