Drug Facts
Topical Burn Cream Plus Pain Relief
Burn Cream
FDA Label NDC 37945-212
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Bio-medical & Pharmaceutical Manufacturing Corporation for the product Burn Cream (NDC 37945-212). 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
Active Ingredient Purpose
Tetracaine (1.0%).......................Pain & Itch Relief
Purpose
• For temporary relief of minor aches and pains of muscles and joints commonly assoicated 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
Bio-Medical & Pharm. Mfg. Corp.
4311 South Dr., Houston, TX 77053-4820
281.835.8051 www.bio-medicalmanufacturing.com
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