Label: LIDOCAINE NUMBING CREAM- lidocaine 5% cream

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

Drug Label Information

Updated March 7, 2024

If you are a consumer or patient please visit this version.

  • Active Ingredient

    Lidocaine HCl 5%

  • Purpose

    Topical anesthetic

  • Usages

    Temporarily relieves the pain and itching due to anorectal disorders.

  • Warnings

    For external use only.

    When using this product

    • avoid contact with eyes
    • do not exceed recommended dosage unlesss directed by a doctor
    • do not use in large quantaties, particularly over large surfaces or blistered areas
    • do not put this product into the rectum by using fingers or any medical devices or applicators

    Stop and ask a doctor if

    • rectal bleeding occurs
    • condition worsens or does not improve within 7 days
    • allergic reaction occurs to ingredients in the product
    • symptoms being treated do not subsise or if redness, irritation, swelling, pain or other symptoms develop or increase
    • symptoms clear up and return within a few days

    Flammable

    • keep away from fire or flame

    If pregnant or breast feading, as a health professional before use.

    Keep out of reach of children

    • 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

    If swallowed, get medical help or contact a Poison Control Center Right Away

  • Directions

    When practical, cleanse the affected area with mild soap and warm water and rinse thoroughly. Gently dry by patting or

    blotting with toilet tissue or soft cloth before applying.

    • Adults and children 12 years and older: apply externally to the affected area up to 6 times a day
    • Children under 12 years of age: consult a doctor.
  • Inactive Ingrediants

    benzyl alcohol, carbomer hompolymer type C, Cl 0-18 triglycerides, cholesterol, lecithin, isopropyl myristate,

    polysorbate 80, propylene glycol, tocopherol, trolamine, water.

  • Package Label

    Label

  • INGREDIENTS AND APPEARANCE
    LIDOCAINE NUMBING CREAM 
    lidocaine 5% cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73581-106
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LIDOCAINE HYDROCHLORIDE ANHYDROUS (UNII: EC2CNF7XFP) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE ANHYDROUS5 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    C10-18 TRIGLYCERIDES (UNII: 43AGM4PHPI)  
    CHOLESTEROL (UNII: 97C5T2UQ7J)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    WATER (UNII: 059QF0KO0R)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    CARBOMER HOMOPOLYMER TYPE C (UNII: 4Q93RCW27E)  
    HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:73581-106-06170 mL in 1 JAR; Type 0: Not a Combination Product03/07/2024
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01703/07/2024
    Labeler - YYBA Corp (006339772)