Label: SHEFFIELD LIDOCAINE- lidocaine cream

  • NDC Code(s): 11527-191-30
  • Packager: Sheffield Pharmaceuticals LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated November 30, 2023

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient

    Lidocaine  4%

  • Purpose

    Topical anesthetic

  • Uses

    • Temporarily relieves minor pain
  • Warnings

    For external use only

    Do not use

    • on large areas of the body or on cut,irritated or swollen skin
    • on puncture wounds
    • for more than one week without consultanting a doctor

    When using this product

    use only as directed. read and follow all directions and warnings on this carton.

    do notallow contact with the eyes

    do not bandage or apply local heat (such as heating pads) to the area of use.

    Stop use and ask a doctor if

    • condition worsens
    • symptons persist for more than 7 days or clear up and occur again within a few days.
    • If pregnant or breast feeding, ask a health professional before use.

    Keep this and all drugs out of the reach of children and pets.

    If swallowed, get medical help or contact Poison Control Center right away.

  • Directions

    • Adults and children over 12 years: 
    • apply a thin layer ot affected area every 6 t o8 hours, not to exceed 3 applications in a 24 hour period
    • Children under 12 years  or younger: ask a doctor

  • Other information

    • Store at controlled room temperature 20°-25°C (68°-77°F)
  • Inactive ingredients

    Benzyl Alcohol, Carbomer, Cholesterol, Hydrogenated Lecithin, Polysorbate 80,  Propylene Glycol, Tocopheryl Acetate, Trolamine, Water (purified)

  • Questions?(

  • Principal Panel-Tube

    Sheffield  NDC 11527-191-30

    4% Lidocaine

    Topical Anesthetic Cream

    NET WT. 30g (1.06 oz)

    Principal Panel-Tube

    Principal Panel-Tube
  • Principal Panel - Carton

    Sheffield    NDC 11527-191-30

    4% Lidocaine

    Topcial Anestheic Cream 

    NET WT. 30g (1.06 oz)

    Lidocaine 30g Carton

    Lidocaine 30g Carton
  • INGREDIENTS AND APPEARANCE
    SHEFFIELD LIDOCAINE 
    lidocaine cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11527-191
    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 940 (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:11527-191-301 in 1 CARTON12/22/2020
    130 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01712/22/2020
    Labeler - Sheffield Pharmaceuticals LLC (151177797)
    Registrant - Sheffield Pharmaceuticals LLC (151177797)
    Establishment
    NameAddressID/FEIBusiness Operations
    Sheffield Pharmaceuticals LLC151177797manufacture(11527-191)
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