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

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 October 30, 2018

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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 finalpart34610/01/2003
    Labeler - Ferndale Laboratories, Inc. (005320536)
    Establishment
    NameAddressID/FEIBusiness Operations
    Ferndale Laboratories, Inc.005320536manufacture(0496-0883)
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