Label: 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 April 21, 2023

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  • Active Ingredient

    Lidocaine 5%

  • Purpose

    Local Anesthetic

  • Uses

    for temporary relief of local and anorectal discomfort associated with anorectal disorder or inflammation

  • Warnings

    Warnings ( For extemal use only )

  • When using this product

    do not exceed the recommended daily dosage unless directed by a doctor.

    certain persons can develop allergic reactions to ingredients in this product.

    do not put this product into the rectum by using finger or any medical device or applicator.

  • Stop use

    n/a

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children

    Incase of accidental ingestion , seek medical attention immediately

  • Directions

    Adults : When practical , cleanse the affected area with mild soap and warm water and rinse thoroughly. Gently dry by patting or blottingwith toilet tissue or a soft cloth , before application of this product.

    Apply up to 6 times a day,

    Children up under 12 years of age: consult a doctor.

  • Other Information

    keep away from direct sunlight or heata.

    store in room temperature ( 59-86 F/15-30 C )

  • Inactive Ingredients

    Allantoin, Aloe Barbadensis Leaf Juice, Benzyl Alcohol, Carbomer, Cholesterol, Dimenthyl Isosorbide, Disodium EDTA , Hydrogenated Polydece, Lecithin, Neopentyl Glycol Dicaprylate/Dicaprate, Acetate, Trideceth-6, Triethanolamine

  • Package Label - Principal Display Panel

    83365-003-01

  • INGREDIENTS AND APPEARANCE
    LIDOCAINE 
    lidocaine cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:83365-003
    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
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM POLYACRYLATE (2500000 MW) (UNII: 05I15JNI2J)  
    ALLANTOIN (UNII: 344S277G0Z)  
    EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
    HYDROGENATED POLYDECENE TYPE I (UNII: U333RI6EB7)  
    LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
    NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    ALPHA-TOCOPHEROL (UNII: H4N855PNZ1)  
    TRIDECETH-6 (UNII: 3T5PCR2H0C)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    DIMETHYL ISOSORBIDE (UNII: SA6A6V432S)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    CHOLESTEROL (UNII: 97C5T2UQ7J)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:83365-003-0156 g in 1 BOX; Type 0: Not a Combination Product04/21/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalM01504/21/2023
    Labeler - Sichuan Gumo Brand Management Co.,Ltd (406945503)
    Establishment
    NameAddressID/FEIBusiness Operations
    Sichuan Gumo Brand Management Co.,Ltd406945503manufacture(83365-003)
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