Penichillin
FDA Label NDC 54723-014
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Sambria Pharmaceuticals, Llc for the product Penichillin (NDC 54723-014). 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, uses, warnings, keep out of reach of children, directions, 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 2%
Purpose
External Analgesic
Uses
For temporary relief of pain and itching due to minor skin irritation.
Warnings
For external use only. Avoid contact with eyes. Do not use in large quantities, particularly over raw surfaces or blistered areas.
Stop use and ask doctor if condition worsens or if symptoms persist for more than 7 days or clear up and occur again within a few days.
Keep out of reach of children. If product is swallowed, get medical help or contact a poison control center immediately.
Keep Out Of Reach Of Children
If swallowed, get medical help or contact a Poison Control Center right away.
Directions
For adults and children two-years or older: Apply to affected area not more than 3 or 4 times daily.
Children under 2 years of age: consult a physician. Apply in a circular motion for 30 to 60 seconds.
Inactive Ingredients
Aqua (Deionized Water), Arnica Montana Flower Extract, C13-14 Isoparaffin, Chrondroitin Sulfate, Emu Oil, Ethoxydiglycol, Ethylhexyglycerin,
Glucosamine Sulfate, Isopropyl Palmitate, Laureth-7, Melaleuca Alternifolia (Tea Tree) Oil, Methylsulfonylmethane (MSM), Phenoxyethanol,
Polyacrylamide, Propylene Glycol,StearicAcid, Triethanolamine.
Other Information
Protect this product from excessive heat and direct sun. Never tested on animals, just late clients.
Product Label
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