Label: ECLIPSE TOPICAL ANESTHETIC- lidocaine hydrochloride cream

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

DISCLAIMER: Most OTC drugs are not reviewed and approved by 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 August 6, 2018

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  • Active Ingredient

    Lidocaine HCL 4.00% w/w

    Purpose

    External Analgesic

  • Uses

    For temporary relief of pain and itching due to minor skin irritation.

  • Warnings

    ​For external use only

    ​ ​Avoid contact with eyes

    ​Do not use​ in large quantities, particularly over raw surfaces or blistered areas

  • STOP USE

    ​Stop use and ask a doctor if​

    • Condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days.  Discontinue use.

  • KEEP OUT OF REACH OF CHILDREN

    ​Keep out of reach of children​

    • If product is swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    For adults and children two-years or older: Apply to affected area not more than 3 or 4 times daily.  Children under 2 years of age: consult a physician.  Apply in a circular motion for 50 to 60 seconds.

  • Inactive Ingredients

    Aqua (Deionized Water), Arnica Montana Flower Extract, C13-14 Isoparaffin, Chrondroitin Sulfate, Emu Oil, Ethoxydiglycol, Ethylhexyglycerin, Glucosamine Sulfate, Isopropyl Palmitate, Laureth-7, Melaleuca Alternifolia (Tea Tree) Oil, Methylsulfonylmethane (MSM), Phenoxyethanol, Polyacrylamide, Propylene Glycol, Stearic Acid, Triethanolamine.

  • ​Other Information

    Protect this product from excessive heat and direct sun.

  • ​Questions or Comments?

    FDA Registered: NDC No. 54723-667-10

    800-759-6876

  • PRINCIPAL DISPLAY PANEL

    Packet

  • INGREDIENTS AND APPEARANCE
    ECLIPSE TOPICAL ANESTHETIC 
    lidocaine hydrochloride cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54723-667
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE ANHYDROUS40 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)  
    C13-14 ISOPARAFFIN (UNII: E4F12ROE70)  
    SODIUM CHONDROITIN SULFATE (PORCINE; 5500 MW) (UNII: H5BJH23Z9A)  
    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)  
    MELALEUCA ALTERNIFOLIA LEAF (UNII: G43C57162K)  
    DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    POLYACRYLAMIDE (10000 MW) (UNII: E2KR9C9V2I)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:54723-667-102 g in 1 PACKET; Type 0: Not a Combination Product02/01/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34808/20/2015
    Labeler - Sambria Pharmaceuticals (078676259)
    Establishment
    NameAddressID/FEIBusiness Operations
    A.I.G. Technologies, Inc.171837367manufacture(54723-667)
    Establishment
    NameAddressID/FEIBusiness Operations
    JP Packaging LLC151369456repack(54723-667)
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