Label: BODY ACTION PRODUCTS BUTT EZE BENZOCAINE- benzocaine gel

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

Drug Label Information

Updated November 10, 2023

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  • Drug Facts

  • Active Ingredient

    Benzocaine 5%

    Purpose

    Anorectal (Hemorrhoidal) Gel

  • Uses

    • For temporary relief of pain or soreness in the perianal area.
  • Warnings

    For external use only.

    • Avoid contact with the eyes.
    • Certain persons can develop allergic reactions from ingredients in this product. If the symptom being treated does not subside or if redness, irritation, swelling, pain or other symptoms develop or increase, discontinue use and consult a doctor.

    Keep out of reach of children.

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

  • Directions

    • When practial, 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 to the affected area up to 6 times daily.
  • Other Information

    Do not use if safety seal is broken or missing.

  • Inactive Ingredients

    Cannabis Sativa (Hemp) Seed Oil, Hydroxyethylcellulose, Methylparaben, PEG-8, Polysorbate 20, Propylene Glycol, Propylparaben, Water.

  • Package Labeling:

    Label

  • INGREDIENTS AND APPEARANCE
    BODY ACTION PRODUCTS BUTT EZE BENZOCAINE 
    benzocaine gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70742-286
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE50 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    CANNABIS SATIVA SEED OIL (UNII: 69VJ1LPN1S)  
    HYDROXYETHYL CELLULOSE, UNSPECIFIED (UNII: T4V6TWG28D)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70742-286-0060 mL in 1 BOTTLE; Type 0: Not a Combination Product04/29/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01504/29/2022
    Labeler - PRODUCT MAX GROUP INC (134893911)
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