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
  • Marketing Status: OTC monograph not final

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 May 13, 2020

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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

    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 not finalpart34801/03/2011
    Labeler - Ferndale Laboratories, Inc. (005320536)
    Establishment
    NameAddressID/FEIBusiness Operations
    Ferndale Laboratories, Inc.005320536manufacture(0496-0882)
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