Label: 4 LIDOCAINE TOPICAL ANESTHETIC- lidocaine cream

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

Drug Label Information

Updated October 24, 2023

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  • Drug Facts

  • Active ingredient

    Active ingredient

    Purpose

    Topical Analgesic

  • Uses

    temporarily relieves pain and itching due to:

    • minor cuts
    • minor scrapes
    • sunburn
    • minor skin irritations
    • minor burns
    • insect bites
  • Warnings

    For external use only.

    When using this product

    • do not use in or near the eyes
    • do not use in large quantities, particularly over raw surfaces 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

    Do not apply over large areas of the body.

    Keep out of reach of children.

    If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

  • Directions

    • Adults and children 2 years and older: Apply externally to the affected area up to 3-4 times daily.
    • Children under 2 years: Consult a doctor.
  • Other information

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

    aloe barbadensis leaf extract, benzyl alcohol, carbomer 940, cetyl alcohol, cholesterol, di-alpha tocopherol, glycerin, hydrogenated lecithin, isopropyl myristate, polysorbate 80, propylene glycol, purified water, stearic acid, trolamine

  • Questions & Comments?

    1-800-645-2158

  • Package Labeling:

    Label

  • INGREDIENTS AND APPEARANCE
    4 LIDOCAINE TOPICAL ANESTHETIC 
    lidocaine cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0536-1267
    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
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    CHOLESTEROL (UNII: 97C5T2UQ7J)  
    .ALPHA.-TOCOPHEROL, DL- (UNII: 7QWA1RIO01)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0536-1267-2015 g in 1 BOX; Type 0: Not a Combination Product04/30/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01704/30/2020
    Labeler - RUGBY LABORATORIES (079246066)
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