Label: PREDATOR- lidocaine hydrochloride cream
- NDC Code(s): 54723-150-03
- Packager: Sambria Pharmaceuticals, LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
NOTE: Most over the counter (OTC) are not reviewed and approved by the FDA. However, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
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- Information for Patients
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.Close
- active ingredients
lidocaine HCL 4%Close
- Other ingredients
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, TriethanolamineClose
- KEEP OUT OF REACH OF CHILDREN
This product should be kept out of the reach of children uner twelve (12) years of age.Close
- Method of Application
Rub 1ml in circular motion for 6 0seconds on effected area.Close
- DOSAGE & ADMINISTRATION
Rub 1ml in cicular motion for 60 seconds on effected area.Close
- INGREDIENTS AND APPEARANCE
lidocaine hcl cream
Product Information Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:54723-150 Route of Administration TOPICAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength LIDOCAINE HYDROCHLORIDE (LIDOCAINE) LIDOCAINE HYDROCHLORIDE 400 mg in 1 mg Inactive Ingredients Ingredient Name Strength WATER ARNICA MONTANA FLOWER C13-14 ISOPARAFFIN CHONDROITIN SULFATE (BOVINE) EMU OIL DIETHYLENE GLYCOL MONOETHYL ETHER ETHYLHEXYLGLYCERIN GLUCOSAMINE SULFATE ISOPROPYL PALMITATE LAURETH-7 TEA TREE OIL DIMETHYL SULFONE PHENOXYETHANOL POLYACRYLAMIDE (10000 MW) PROPYLENE GLYCOL STEARIC ACID TRIETHANOLAMINE BENZOATE Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:54723-150-03 400 mg in 1 PACKAGE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 02/11/2013 Labeler - Sambria Pharmaceuticals, LLC (078676259) Establishment Name Address ID/FEI Business Operations Pure Source 969241041 manufacture(54723-150)