Label: BLOOP FISSURE HEALING ANORECTAL TOPICAL- lidocaine cream

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated November 30, 2023

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  • ACTIVE INGREDIENT

    Lidocaine 5%

  • PURPOSE

    Anorectal (hemorrhoidal)

  • INDICATIONS & USAGE

    • Helps relieve the pain, itching, and burning associated with hemorrhoids, fissures, and other anorectal disorders
  • WARNINGS

    For external use only (skin of the perianal area and anal canal).

    When using this product

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

    Stop use and ask a doctor if

    • condition worsens or does not improve within 7 days
    • rectal bleeding occurs
    • 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
  • 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 immediately.

  • DOSAGE & ADMINISTRATION

    • Gently dry by patting or blotting with toilet tissue or soft cloth before applying
    • Carefully apply medication to the perianal skin and anal canal with a clean finger
    • 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

    Benzyl alcohol, carbomer, cholesterol, euterpe oleracea fruit oil, hydrogenated lecithin, isopropyl myristate, pentaclethra macroloba seed oil, polysorbate 80, propanediol, tocopheryl acetate, triethanolamine, water.

  • PRINCIPAL DISPLAY PANEL

    Carton

  • INGREDIENTS AND APPEARANCE
    BLOOP FISSURE HEALING ANORECTAL TOPICAL 
    lidocaine cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:83838-153
    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
    CARBOMER 940 (UNII: 4Q93RCW27E)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    CHOLESTEROL (UNII: 97C5T2UQ7J)  
    ACAI OIL (UNII: Z0W6766A2W)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N)  
    PROPANEDIOL (UNII: 5965N8W85T)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    PENTACLETHRA MACROLOBA SEED OIL (UNII: OM0BAV5397)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    WATER (UNII: 059QF0KO0R)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:83838-153-011 in 1 CARTON11/14/2023
    128 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01511/14/2023
    Labeler - Three Nations Corp (119050054)
    Registrant - Derma Care Research Labs, LLC (116817470)
    Establishment
    NameAddressID/FEIBusiness Operations
    Derma Care Research Labs, LLC116817470manufacture(83838-153)
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