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

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XOLIDO (LIDOCAINE HCL) CREAM [ASCLEMED USA, INC]
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NDC 76420-451-01
Set ID e29c46ce-6758-41ff-af1a-e99fb67a8c33
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    4%

  • Purpose

    External Anesthetic

  • Uses

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

  • Warning

    For external use only.

    Avoid contact with eyes

    Stop using this product and ask doctor If

    • symptoms last for more than seven days, or clear up and occur again within a few days
    • if redness, irritation, swelling, pain or other symptoms increase

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    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.

  • Additional Information

    Store at room temperature.

  • 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

    NDC 76420-451-01

    Xolido XP 4%

    Pain Relief Cream

    4 OZ (118 mL)

    Distributed by:

    Enovachem Manufacturing

    Torrance, CA 90501

    (310) 218-4146

    Principal Display Panel

  • INGREDIENTS AND APPEARANCE
    XOLIDO 
    lidocaine hcl cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76420-451
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE ANHYDROUS4 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:76420-451-01118 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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