Label: LIDOCAINE cream

  • NDC Code(s): 10135-672-96, 10135-672-99
  • Packager: Marlex Pharmaceuticals Inc
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated November 8, 2023

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  • SPL UNCLASSIFIED SECTION

    LIDOCAINE 4%- lidocaine cream

    MarlexPharmaceuticals, Inc.

    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.

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    Lidocaine 4% Topical

    Drug Facts

  • Active ingredient

    Lidocaine 4%

  • Purpose

    Pain & Itch Relief

  • Use

    for the temporary relief of pain associated with minor burns, sunburn, minor cuts, scrapes, insect bites, and minor skin irritations

  • Warnings

    For external use only. Avoid contact with eyes. Not for prolonged use.

    Donotusein large quantities, particularly over raw surfaces or blistered areas.

    Stop use and ask a doctor if

    • condition worsens
    • symptoms persist for more than 7 days or clear up and occurs again within a few days
    • rash or irritation develops, persists, or increases

    If pregnant or breast-feeding,

    ask a health professional before use.

    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 of age and older:apply to affected area not more than 3 to 4 times daily

    Children under 2 years of age: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) 
  • Inactive ingredients

    Benzyl alcohol, carbopol 940, hydrogenated lecithin, polysorbate 80, propylene glycol, purified water, trolamine and vitamin E acetate

  • PRINCIPAL DISPLAY PANEL- 15gTubeCarton

    Lidocaine 4% Topical Anesthetic Cream

    Pain & Itch Relief Cream NET WT. 0.5 oz.(15g)

    672-96

  • PRINCIPAL DISPLAY PANEL-30gTube Carton

    Lidocaine 4% Topical Anesthetic Cream

    Pain & Itch Relief Cream NET WT. (30g)

    672-99

  • INGREDIENTS AND APPEARANCE
    LIDOCAINE 
    lidocaine cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10135-672
    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 (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E)  
    CHOLESTEROL (UNII: 97C5T2UQ7J)  
    HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:10135-672-961 in 1 CARTON12/01/2018
    115 g in 1 TUBE; Type 0: Not a Combination Product
    2NDC:10135-672-991 in 1 CARTON12/01/2018
    230 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01712/01/2018
    Labeler - Marlex Pharmaceuticals Inc (782540215)
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