Label: BUNNIES BUM HEMORRHOIDAL NUMBING- lidocaine cream

  • NDC Code(s): 84308-159-01
  • Packager: FloCal Distributors LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated July 5, 2024

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

  • ACTIVE INGREDIENT

    Lidocaine 5%

  • PURPOSE

    Topical anesthetic

  • INDICATIONS & USAGE

    Helps relieve the local itching and pain associated with anorectal disorders or inflammation.

  • WARNINGS

    For external use only.

    When using this product

    • avoid contact with eyes
    • do not exceed recommended dosage unless directed by a doctor
    • do not put this into the rectum by using fingers or any mechanical device or applicator

    Stop use and ask a doctor if

    • rectal bleeding occurs
    • condition worsens or does not improve within 7 days
    • allergic reaction occurs to ingredients in this product
    • symptom being treated does not subside or if redness, irritation, swelling, pain or other symptoms develop or increase
    • symptoms clear up and return within a few days
  • PREGNANCY OR BREAST FEEDING

    Ask a health professional before use.

  • KEEP OUT OF REACH OF CHILDREN

    If swallowed, get medical help or contact a Poison Control Center right away.

  • DOSAGE & ADMINISTRATION

    • When practical, clean 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 INGREDIENT

    Ascorbic acid, benzyl alcohol, boswellia serrata extract, bromelain, carbomer, cholesterol, curcuma long (turmeric) root extract, glucose, glycerin, hydrogenated lecithin, isopropyl myristate, panax ginseng root extract, polysorbate 80, propylene glycol, salix alba (willow) bark extract, tocopheryl acetate, triethanolamine, water.

  • PRINCIPAL DISPLAY PANEL

    Label

  • INGREDIENTS AND APPEARANCE
    BUNNIES BUM HEMORRHOIDAL NUMBING 
    lidocaine cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:84308-159
    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
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    CARBOMER 940 (UNII: 4Q93RCW27E)  
    ANHYDROUS DEXTROSE (UNII: 5SL0G7R0OK)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    TURMERIC (UNII: 856YO1Z64F)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    ASIAN GINSENG (UNII: CUQ3A77YXI)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    WATER (UNII: 059QF0KO0R)  
    CHOLESTEROL (UNII: 97C5T2UQ7J)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    ASCORBIC ACID (UNII: PQ6CK8PD0R)  
    INDIAN FRANKINCENSE (UNII: 4PW41QCO2M)  
    BROMELAINS (UNII: U182GP2CF3)  
    HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N)  
    SALIX ALBA BARK (UNII: 205MXS71H7)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:84308-159-0128 g in 1 TUBE; Type 0: Not a Combination Product07/08/2024
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01507/08/2024
    Labeler - FloCal Distributors LLC (128775688)
    Registrant - Derma Care Research Labs LLC (116817470)
    Establishment
    NameAddressID/FEIBusiness Operations
    Derma Care Research Labs LLC116817470manufacture(84308-159)