Label: LIDOCREAM 5- 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 November 11, 2015

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  • Active ingredient

    Lidocaine 5% W/W

  • Purpose

    Topical Anesthetic

  • 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.

  • Uses

    For the temporary relief of pain and itching due to anorectal disorders

  • Warnings

    For external use only

    When using this product

    • Avoid contact with the eyes 
    • Do not put in rectum
    • Do not exceed recommended dosage unless directed by a doctor


    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
    • rectal bleeding occurs
    • redness irritation, swelling, pain or other symptoms develop or increase
  • Directions

    • Adults 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 a soft cloth before application of this product
    • Apply externally to the affected area up to 6 times daily.
    • Children under 12 years of age: consult a doctor
  • Inactive ingredients

    Aloe Barbadensis Leaf Extract, Benzyl Alcohol, Carbomer, Disodium EDTA, Glycerin, Glyceryl Monooleate, SD Alcohol 40-B, Simmondsia Chinensis (Jojoba) Seed Oil, Water

  • Packaging

    LidoCream

  • INGREDIENTS AND APPEARANCE
    LIDOCREAM 5 
    lidocaine cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52763-501
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE5 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    GLYCERYL OLEATE (UNII: 4PC054V79P)  
    ALCOHOL (UNII: 3K9958V90M)  
    SIMMONDSIA CHINENSIS SEED (UNII: D24K2Q1F6H)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:52763-501-12120 g in 1 JAR; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34612/01/2010
    Labeler - Golden Touch LLC (194284147)
    Establishment
    NameAddressID/FEIBusiness Operations
    Golden Touch LLC194284147manufacture(52763-501)
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