Label: LIDOCAINE ANESTHETIC CREAM- lidocaine cream

  • NDC Code(s): 69375-005-30
  • Packager: Nationwide Pharmaceutical LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated January 31, 2024

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredients

    Lidocaine 4% w/w

  • Purpose

    Local Anesthetic

  • Uses

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

  • Warnings

    For external use only.

    When using this product

    • do not get into eyes.
    • do not exceed the recommended daily dosage unless directed by a doctor
    • do not use 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.

    If pregnant or breastfeeding, ask a health professional before use.

    Keep out of reach of children. If swallowed, get 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 of age. Consult a doctor.
  • Other Information

    Store at USP controlled room temperature 20-25 °C (68-77 °F).

  • Inactive ingredients

    Benzyl Alcohol, Carbomer, Cholesterol, Hydrogenated Lecithin, Isopropyl Myristate, Polysorbate 80, Propylene Glycol, Purified Water, Trolamine, Vitamin E Acetate.

  • Questions?

    1-800-697-3329

  • PRINCIPAL DISPLAY PANEL - 28 g Tube Box

    Nationwide
    Pharmaceutical

    NDC 69375-0005-30

    4% Lidocaine
    Topical Anesthetic Cream

    NET WT 1 oz ( 28 g)

    PRINCIPAL DISPLAY PANEL - 28 g Tube Box
  • INGREDIENTS AND APPEARANCE
    LIDOCAINE ANESTHETIC CREAM 
    lidocaine cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69375-005
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Lidocaine (UNII: 98PI200987) (Lidocaine - UNII:98PI200987) Lidocaine4 g  in 100 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)  
    Isopropyl Myristate (UNII: 0RE8K4LNJS)  
    Polysorbate 80 (UNII: 6OZP39ZG8H)  
    Trolamine (UNII: 9O3K93S3TK)  
    .ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)  
    Product Characteristics
    ColorWHITEScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69375-005-301 in 1 BOX06/01/2022
    128 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph drugM01706/01/2022
    Labeler - Nationwide Pharmaceutical LLC (079265801)
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