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.

Drug Label Information

Updated 02/13

If you are a consumer or patient please visit this version.

  • 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.

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  • active ingredients

    lidocaine HCL 4%

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  • 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, Triethanolamine

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  • KEEP OUT OF REACH OF CHILDREN

    This product should be kept out of the reach of children uner twelve (12) years of age.

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  • PURPOSE

    Pain relief

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  • Method of Application

    Rub 1ml in circular motion for 6 0seconds on effected area.

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  • DOSAGE & ADMINISTRATION

    Rub 1ml in cicular motion for 60 seconds on effected area.

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  • INGREDIENTS AND APPEARANCE
    PREDATOR 
    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)
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