PREDATOR (LIDOCAINE HYDROCHLORIDE) CREAM [SAMBRIA PHARMACEUTICALS, LLC]

PREDATOR (LIDOCAINE HYDROCHLORIDE) CREAM [SAMBRIA PHARMACEUTICALS, LLC]
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NDC 54723-101-02
Set ID 9cc2db6f-70eb-4207-b831-34fb1e3bb5af
Category HUMAN OTC DRUG LABEL
Packager Sambria Pharmaceuticals, LLC
Generic Name
Product Class Amide Local Anesthetic, Antiarrhythmic
Product Number
Application Number PART348
  • WARNINGS

    For external use only

    Avoid contact with eyes

    If symptoms persist for more than seven days, or clear up and occur again within a few days, discontinue use and consult physician

    If redness, irritation, swelling, pain or ot5her symptoms increase, discontinue use and consult physician

    If swallowed consult physician.

  • active ingredients

    lidocaine HCL 4%

  • 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

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children

  • PURPOSE

    External anesthetic

  • DOSAGE & ADMINISTRATION

    For adults and children two years or older, apply externally to the affected area. Do not use more than three to four times per day.

  • Uses

    For temporary relief of pain and itching and minor skin irratations due to minor cuts and scrapes, sunburn and minor burns. Also used for temporary relief of itching associated with minor skin irritations and rashes due to insect bites, poison ivy, poison oak and poison sumac, soaps, detergetns, cosmetics and jewelry.

  • PRINCIPAL DISPLAY PANEL

    image description

  • INGREDIENTS AND APPEARANCE
    PREDATOR 
    lidocaine hydrochloride cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54723-101
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE400 mg  in 1 mg
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)  
    C13-14 ISOPARAFFIN (UNII: E4F12ROE70)  
    CHONDROITIN SULFATE (BOVINE) (UNII: 6IC1M3OG5Z)  
    EMU OIL (UNII: 344821WD61)  
    DIETHYLENE GLYCOL MONOETHYL ETHER (UNII: A1A1I8X02B)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    GLUCOSAMINE SULFATE (UNII: 1FW7WLR731)  
    ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)  
    LAURETH-7 (UNII: Z95S6G8201)  
    TEA TREE OIL (UNII: VIF565UC2G)  
    DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    POLYACRYLAMIDE (10000 MW) (UNII: E2KR9C9V2I)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TRIETHANOLAMINE BENZOATE (UNII: M3EN4GC19W)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:54723-101-02400 mg in 1 PACKAGE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34802/11/2013
    Labeler - Sambria Pharmaceuticals, LLC (078676259)
    Establishment
    NameAddressID/FEIBusiness Operations
    Pure Source969241041manufacture(54723-101)

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