Label: LIDOCAINE HCL 4% ointment

  • NDC Code(s): 63868-451-72
  • Packager: CHAIN DRUG MARKETING ASSOCIATION INC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

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.

Drug Label Information

Updated April 12, 2022

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  • ACTIVE INGREDIENT

    Lidocaine HCl 4%

  • INACTIVE INGREDIENT

    benzyl alcohol, carbomer, hydrogenated lecithin, polysorbate 80, propylene glycol, purified water, triethanolamine, vitamin E

  • DOSAGE & ADMINISTRATION

    Adults and children 12 years and older: apply a thin layer to affected area every 6 to 8 hours, not to exceed 3 to 4 applications in a 24-hour period.

    BEFORE AND AFTER APPLYING, WASH HANDS WITH SOAP AND WATER.

    Children under 12 years: ask a doctor

  • INDICATIONS & USAGE

    temporary relieves minor joint and muscle 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 consulting a doctor.

    When using this product use only as directed. Read and follow all directions and warnings on this carton, do not allow 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, symptoms 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 out of reach of children and pets.

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

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children and pets.

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

  • PURPOSE

    Topical anesthetic

  • PRINCIPAL DISPLAY PANEL

    1

  • INGREDIENTS AND APPEARANCE
    LIDOCAINE HCL 4% 
    lidocaine hcl 4% ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63868-451
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE ANHYDROUS4 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    .ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)  
    WATER (UNII: 059QF0KO0R)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    CARBOMER 940 (UNII: 4Q93RCW27E)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63868-451-7276.5 g in 1 BOTTLE; Type 0: Not a Combination Product10/28/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34810/28/2020
    Labeler - CHAIN DRUG MARKETING ASSOCIATION INC (011920774)
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