XOLIDO (LIDOCAINE HCL) CREAM [ASCLEMED USA, INC]

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XOLIDO (LIDOCAINE HCL) CREAM [ASCLEMED USA, INC]
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NDC 76420-449-60
Set ID f2b463d7-3fcf-4b2c-8ba2-8e51e3290de2
Category HUMAN OTC DRUG LABEL
Packager Asclemed USA, Inc
Generic Name
Product Class Amide Local Anesthetic, Antiarrhythmic
Product Number
Application Number PART348
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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active Ingredients

    Lidocaine HCl 2%

  • Purpose

    External Anaesthetic

  • Uses

    For temporary relief of pain and itching and minor skin irritations due to minor cuts and scrapes, sunburn, and minor burns.

  • 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 day, discontinue use and consult physician.

     
    - If redness, irritation, swelling, pain or other symptoms increase, discontinue use and consult physician.

     
    - Keep out of reach of children.  If swallowed, consult physician.
  • Directions

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

  • Inactive Ingredients

    Aqua (Deionized Water), C13-14 Isoparaffin, Glyceryl Stearate, Helianthus Annuus (Sunflower) Seed Oil, Isopropyl Myristate, Laureth-7, Methylisothiazolinone, Polyacrylamide, Stearic Acid.

  • Principal Display Panel

    Xolido 2%

    Pain Relief Cream

    4 oz (118 mL)

    Distributed by:

    Enovachem

    PHARMACEUTICALS

    Torrance, CA 90501

    (310) 320-0100

    Principal Display Panel
  • INGREDIENTS AND APPEARANCE
    XOLIDO 
    lidocaine hcl cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76420-449
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE ANHYDROUS2 g  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    C13-14 ISOPARAFFIN (UNII: E4F12ROE70)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    HELIANTHUS ANNUUS FLOWERING TOP (UNII: BKJ0J3D1BP)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    LAURETH-7 (UNII: Z95S6G8201)  
    METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:76420-449-60118 mL in 1 BOTTLE; Type 0: Not a Combination Product04/05/2013
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34804/05/2013
    Labeler - Asclemed USA, Inc (059888437)
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