Label: LIDOCAINE NUMBING CREAM- lidocaine cream

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph 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 June 14, 2022

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  • DRUG FACTS:

  • Active Ingredient:

    Lidocaine HCl 5.0%

  • Purpose

    • External Analgesic
  • Uses:

    For the temporary relief of pain and discomfort associated with anorectal disorders.

  • Warnings:

    • For external use only. If condition worsens or does not improve within 7 days, consult a doctor.
  • When using this product,

    • Do not exceed the recommended daily dosage unless directed by a doctor.
    • In case of bleeding, consult a doctor promptly.
    • Do not put this product into the rectum by using fingers or any mechanical device or applicator.
    • Keep out of reach of children.
    • If swallowed, get medical help or contact the Poison Control Center immediately.
    • If pregnant or breast feeding, ask a health professional before use.
  • Directions:

    Children under 12: Consult a doctor.

    Adults and children 12 years and older: For optimum results cleanse the affected area with mild soap and warm water and rinse thoroughly. Gently dry by patting or blotting with toilet tissue or a clean, soft cloth before application of this product. Apply externally up to 6 times per day.

  • Keep out of reach of children.

  • Inactive Ingredients

    Benzyl Alcohol, Carbomer 940, Cholesterol, Hydrogenated Lecithin, Isopropyl Myristate, Polysorbate 80, Propylene Glycol, Purified Water, Trolamine and Vitamin E Acetate

  • Other Information:

    Store at room temperature. Avoid direct sunlight. Do not use if tamper evident packaging has been breached or is missing. See bottom of this jar for lot number and expiry date.

    Distributed by: Wellspring Airmont, NY 10952 U.S.A.

  • Packaging label

    LIDO5_55oz_label

  • INGREDIENTS AND APPEARANCE
    LIDOCAINE NUMBING CREAM 
    lidocaine cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55629-050
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE50 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    CARBOMER 940 (UNII: 4Q93RCW27E)  
    CHOLESTEROL (UNII: 97C5T2UQ7J)  
    LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55629-050-55156 mL in 1 JAR; Type 0: Not a Combination Product06/14/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34606/14/2022
    Labeler - ONE2ZEE LIMITED LIABILITY COMPANY (078656111)
    Registrant - ONE2ZEE LIMITED LIABILITY COMPANY (078656111)
    Establishment
    NameAddressID/FEIBusiness Operations
    YASH PHARMACEUTICALS871409551manufacture(55629-050)
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