Label: LIDOCAINE cream

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 31, 2024

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • 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 irritation
    • insect bites
  • Directions

    • Adult and children 2 years and older: Apply externally to the affected area up to 3 to 4 times a day.
    • Children under 2 years of age: Consult a doctor.
  • Warnings

    For external use only.

    Do not use

    • in or near the eyes
    • in large quantities, particularly over raw 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.

  • Other Information

    • May be applied under occlusive dressing.
    • Store at room temperature, 20–25°C (68–77°F) Excursions permitted 15–30°C (59–86°F) [see USP Controlled Room Temperature].
  • Inactive ingredients

    Benzyl Alcohol, Carbopol 940, Hydrogenated Lecithin, Polysorbate 80, Propylene Glycol, Purified Water, Trolamine and Vitamin E Acetate.

  • Questions?

    Call 800-936-3088

  • How Supplied/Storage and Handling

    Lidocaine 4% Cream is supplied in:

    15g tube NDC: 80425-0351-01

    Store at room temperature, 20–25°C (68–77°F) Excursions permitted 15–30°C (59–86°F) [see USP Controlled Room Temperature].

  • PRINCIPAL DISPLAY PANEL

    label 1

  • INGREDIENTS AND APPEARANCE
    LIDOCAINE 
    lidocaine cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:80425-0351(NDC:39328-024)
    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)  
    HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    Product Characteristics
    ColorwhiteScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:80425-0351-11 in 1 CARTON07/31/2023
    115 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01707/31/2023
    Labeler - Advanced Rx Pharmacy of Tennessee, LLC (117023142)
    Establishment
    NameAddressID/FEIBusiness Operations
    Advanced Rx Pharmacy of Tennessee, LLC117023142repack(80425-0351)
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