Label: LMX4- lidocaine cream

  • NDC Code(s): 0496-0882-05, 0496-0882-06, 0496-0882-07, 0496-0882-15, view more
    0496-0882-30, 0496-0882-71
  • 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 4% w/w

  • Purpose

    Topical anesthetic

  • Uses

    temporarily relieves pain and itching due to

    • minor cuts
    • minor scrapes
    • minor burns
    • sunburn
    • minor skin irritations
    • insect bites
  • Warnings

    For external use only.

    Do not use

    • in or near the eyes
    • in large quantities, particularly over raw surfaces or blistered areas

    Stop use and ask a doctor if:

    • allergic reaction occurs
    • condition worsens or does not improve within 7 days
    • symptoms clear up and return within a few days
    • redness, irritation, swelling, pain or other symptoms begin or increase
  • Keep out of reach of children.

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

  • Directions


    • Adults and children 2 years and older: Apply externally to the affected area up to 3 to 4 times a day
    • Children under 2 years: Consult a doctor

  • Other Information

    • May be applied under occlusive dressing.

    • 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, cholesterol, hydrogenated lecithin, polysorbate 80, propylene glycol, trolamine, vitamin E acetate, water

  • Package Labels-Principal Display Panels

    Manufactured by Ferndale Laboratories, Inc.

    Ferndale, MI 48220 U.S.A.

    Toll free (888) 548-0900

    www.ferndalelabs.com

    L.M.X.4® is a registered trademark of Ferndale IP, Inc.

    Tegaderm™ is a trademark of 3M Corporation.

    NDC 0496-0882-06 L.M.X.4® 5 x 5 grams

    5x5gcarton

    NDC 0496-0882-07 L.M.X.4® 5 x 5 grams with 10 3M Tegaderm™ Transparent Dressings

    5x5gwtegadermcarton

    NDC 0496-0882-15 L.M.X.4® 15 grams

    15gcarton

    NDC 0496-0882-30 L.M.X.4® 30 grams

    30g Carton R1024

    NDC 0496-0882-71 L.M.X.4® 30 grams with 10 3M Tegaderm™ Transparent Dressings

    30gwtegadermcarton

    NDC 0496-0882-05 L.M.X.4 5 grams

    5g

  • INGREDIENTS AND APPEARANCE
    LMX4 
    lidocaine cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0496-0882
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE40 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    CARBOMER HOMOPOLYMER TYPE C (UNII: 4Q93RCW27E)  
    CHOLESTEROL (UNII: 97C5T2UQ7J)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0496-0882-065 in 1 CARTON01/03/2011
    1NDC:0496-0882-055 g in 1 TUBE; Type 0: Not a Combination Product
    2NDC:0496-0882-075 in 1 BOX01/03/2011
    2NDC:0496-0882-055 g in 1 TUBE; Type 0: Not a Combination Product
    3NDC:0496-0882-1515 g in 1 TUBE; Type 0: Not a Combination Product01/03/2011
    4NDC:0496-0882-3030 g in 1 TUBE; Type 0: Not a Combination Product01/03/2011
    5NDC:0496-0882-055 g in 1 TUBE; Type 0: Not a Combination Product01/03/2011
    6NDC:0496-0882-711 in 1 BOX01/03/2011
    6NDC:0496-0882-3030 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01701/03/2011
    Labeler - Ferndale Laboratories, Inc. (005320536)
    Establishment
    NameAddressID/FEIBusiness Operations
    Ferndale Laboratories, Inc.005320536manufacture(0496-0882)
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