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

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PREDATOR (LIDOCAINE HYDROCHLORIDE) CREAM [SAMBRIA PHARMACEUTICALS, LLC]
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NDC 54723-100-01, 54723-100-11
Set ID f971ea20-10a6-406b-b160-867d3b8c1801
Category HUMAN OTC DRUG LABEL
Packager Sambria Pharmaceuticals, LLC
Generic Name
Product Class Amide Local Anesthetic, Antiarrhythmic
Product Number
Application Number PART348
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  • Active Ingredient

    Lidocaine HCL

  • Purpose

    Topical Pain Reliever

  • Uses

    Temporary relief from minor aches and pains of sore muscles and joints associated with: arthritis - backache - strains - sprains

  • Warnings

    For external use only

    Ask a doctor before you use if

    you have sensitive skin, renal (kidney) and/or hepatic (liver) dysfunction

    When using this product

    • Avoid contact with the eyes or mucous membranes
    • Do not apply to wounds or damaged skin
    • Do not use with other ointments, creams, sprays or liniments
    • Do not apply to irritated skin or if excessive irritation develops
    • Do not bandage
    • Wash hands after use with soap and water

    If pregnant or breast-feeding

    Ask a health professional before use.

    Keep out of the reach of children

    If accidentally ingested, get medical help or contact a Poison Control Center immediately.

  • Directions

    • Adults and children 6 years of age and older: Rub a thin film over affected areas not more than 4 times daily; rigorously rub product onto affected area in a circular motion for 30 to 60 seconds.
    • Children under 6 years of age: Consult a physician
  • Flammable

    Keep away from excessive heat or open flame

  • Storage

    Store in a cool dry place with lid closed tightly.

  • Inactive ingredients

    Polyacrylamide and C13-14 Isoparrafin and Laureth-7, Methylsulfonylmethane, Ethoxydiglycol, Propylene Glycol, Triethanolamine, Emu Oil, Tea Tree Oil, Arnica Montana Extract, Ethylhexylglycerin, Phenoxyethanol, Isopropyl Palmitate, Stearic Acid, Glucosamine Sulfate, Chondroitin Sulfate

  • Questions or Comments

    1-888-246-6601

  • Principal Display Panel

    image of label

  • INGREDIENTS AND APPEARANCE
    PREDATOR 
    lidocaine hydrochloride cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54723-100
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE40 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    POLYACRYLAMIDE (10000 MW) (UNII: E2KR9C9V2I)  
    C13-14 ISOPARAFFIN (UNII: E4F12ROE70)  
    LAURETH-7 (UNII: Z95S6G8201)  
    DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)  
    BIS-ETHOXYDIGLYCOL SUCCINATE (UNII: YGQ120RH3I)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    TRIETHANOLAMINE BENZOATE (UNII: M3EN4GC19W)  
    EMU OIL (UNII: 344821WD61)  
    TEA TREE OIL (UNII: VIF565UC2G)  
    ARNICA MONTANA (UNII: O80TY208ZW)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    GLUCOSAMINE SULFATE (UNII: 1FW7WLR731)  
    CHONDROITIN SULFATE (BOVINE) (UNII: 6IC1M3OG5Z)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:54723-100-111 in 1 CARTON
    1NDC:54723-100-0130 g in 1 JAR
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34812/01/2012
    Labeler - Sambria Pharmaceuticals, LLC (078676259)
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