The following Structured Product Label (SPL) was submitted to the FDA by Sambria Pharmaceuticals, Llc for the product Predator (NDC 54723-150). 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 information for patients, active ingredients, other ingredients, otc - keep out of reach of children, otc - purpose, method of application, dosage & administration, package label.principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
This product is not to be administered orally (mouth) or in the ocular (eye) area.
If used improperly by oral administration the patient should be aware that the production of topical anesthesia may impair swallowing and thus enhance the danger of aspiration. For this reason, any device (including hands and fingers) used to administer this product topically should be cleaned well before possible contact with eyes, intra-nasaly or mouth.
lidocaine HCL 4%
Aqua, Amica Montana Extract, C13-14 Isoparafin, Chondrotin Sulfate, Emu Oil, Ethoxydiglycol, Ethylhexylglycerin, Glucosamine Sulfate, Isopropyl Palmitate, Laureth 7, Melaleuca Alternifoil (Tea Tree) oil, Methylsulfonylmethana (MSM), Phenoxyethanol, Polyacrylamide, Propylene Glycol, Stearic Acid, Triethanolamine
This product should be kept out of the reach of children uner twelve (12) years of age.
Pain relief
Rub 1ml in circular motion for 6 0seconds on effected area.
Rub 1ml in cicular motion for 60 seconds on effected area.
* Please review the disclaimer below.
