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
  • Marketing Status: OTC monograph 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 October 30, 2018

If you are a consumer or patient please visit this version.

  • Active ingredient

    Lidocaine 5% w/w

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  • Purpose

    Local anesthetic

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  • Uses

    temporarily relieves pain and itching due to anorectal disorders

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  • 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.

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  • 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.
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  • Other information

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

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  • Inactive Ingredients

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

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  • 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

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  • INGREDIENTS AND APPEARANCE
    LMX5 
    lidocaine cream
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:0496-0883
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE 50 mg  in 1 g
    Inactive Ingredients
    Ingredient Name Strength
    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 Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0496-0883-30 30 g in 1 TUBE; Type 0: Not a Combination Product 10/01/2003
    2 NDC:0496-0883-15 15 g in 1 TUBE; Type 0: Not a Combination Product 10/01/2003
    3 NDC:0496-0883-97 1 g in 1 POUCH; Type 0: Not a Combination Product 10/01/2003
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part346 10/01/2003
    Labeler - Ferndale Laboratories, Inc. (005320536)
    Establishment
    Name Address ID/FEI Business Operations
    Ferndale Laboratories, Inc. 005320536 manufacture(0496-0883)
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