Label: LMX5- lidocaine cream

  • NDC Code(s): 0496-0883-15, 0496-0883-30, 0496-0883-97
  • Packager: Ferndale Laboratories, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 17, 2024

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  • Active ingredient

    Lidocaine 5% w/w

  • Purpose

    Local anesthetic

  • Uses

    temporarily relieves pain and itching due to anorectal disorders

  • Warnings


    When using this product

    • avoid contact with eyes
    • do not exceed recommended dosage unless directed by a doctor

    Stop use and ask a doctor if

    • rectal bleeding occurs
    • condition worsens or does not improve within 7 days
    • allergic reaction occurs
    • redness, irritation, swelling, pain or other symptoms begin or increase
    • symptoms clear up and return within a few days

    Keep out of reach of children.

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

  • Directions

    • When practical, clean area with mild soap and warm water and rinse thoroughly.  Gently dry by patting or blotting with toilet tissue or soft cloth before applying.
    • Adults and Children 12 years and older:  Apply to the affected area up to 6 times a day.
    • Children under 12 years of age:  Consult a doctor.
  • Other information

    Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature].

  • Inactive Ingredients

    benzyl alcohol, carbomer 940, chloesterol, hydrogenated lecithin, isopropyl myristate, polysorbate 80, propylene glycol, purified water, trolamine, and vitamin E acetate

  • Package Label

    Manufactured for Ferndale Healthcare Inc.

    Ferndale, MI 48220 U.S.A.

    Toll free (888) 548-0900

    www.ferndalehealthcare.com


    L.M.X.5® is a registered trademark of Ferndale, IP Inc.
    30 gram NDC 0496-0883-30

    Carton

  • INGREDIENTS AND APPEARANCE
    LMX5 
    lidocaine cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0496-0883
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE50 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    CARBOMER HOMOPOLYMER TYPE C (UNII: 4Q93RCW27E)  
    CHOLESTEROL (UNII: 97C5T2UQ7J)  
    LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0496-0883-3030 g in 1 TUBE; Type 0: Not a Combination Product10/01/2003
    2NDC:0496-0883-1515 g in 1 TUBE; Type 0: Not a Combination Product10/01/2003
    3NDC:0496-0883-971 g in 1 POUCH; Type 0: Not a Combination Product10/01/2003
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01510/01/2003
    Labeler - Ferndale Laboratories, Inc. (005320536)
    Establishment
    NameAddressID/FEIBusiness Operations
    Ferndale Laboratories, Inc.005320536manufacture(0496-0883)
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