Active Ingredient
Tetracaine 2%
Blt 3 Ointment
FDA Label NDC 70372-729
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Centura Pharmaceuticals Inc for the product Blt 3 (NDC 70372-729). 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 ingredient, purpose, uses, warnings, directions, other information, inactive ingredients, package labeling, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Topical Anesthetic
Uses
For the temporary relief of pain and itching.
Warnings
• For external use only.
• Avoid contact with eyes or mucus membranes.
• Do not apply to open or damaged skin.
• If condition worsens or symptoms persist for
more than seven days, discontinue use and
consult physician.
• If pregnant or breast feeding,contact physician
prior to use.
• Keep out of reach of children. If swallowed,
contact Poison Control Center.
• Do not use if allergic to any ingredient in ointment.
• Do not use in large quantities, particularly over
raw surfaces or blistered areas.
Directions
Adults and children two-years of age or
older: Apply to affected area not more than three to
four times daily. Children under two-years of age:
consult a physician.
Other Information
Store below 77° F (25° C). Avoid
direct sunlight.
Inactive Ingredients
Acrylates, C10-30 Alkyl Acrylate
Crosspolymer, Aqua (Deionized Water), Beeswax, Benzyl
Alcohol, Cetyl Alcohol, Dehydroacetic Acid, Glycerin,
Helianthus Annuus (Sunflower) Oil, Polysorbate 20,
Sodium Hydroxide, Stearic Acid.
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