Label: LIDOCREAM 10- 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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  • Drug Facts

  • Active Ingredient

    Lidocaine 10% 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.

  • INDICATIONS & USAGE

    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 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

  • DOSAGE & ADMINISTRATION

    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 upto 6 times daily • Children under 12 years of age: consult a doctor

  • INACTIVE INGREDIENT

    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

    lido1

  • INGREDIENTS AND APPEARANCE
    LIDOCREAM 10 
    lidocaine cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52763-101
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE10 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:52763-101-601 in 1 CARTON
    160 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34605/05/2015
    Labeler - Golden Touch LLC (194284147)
    Establishment
    NameAddressID/FEIBusiness Operations
    Golden Touch LLC194284147manufacture(52763-101)
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