Label: HEMORRHOID ANESTHETIC- mineral oil, petrolatum, phenylephrine hcl ointment

  • NDC Code(s): 52000-057-02
  • Packager: Universal Distribution Center LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated May 14, 2024

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

  • ACTIVE INGREDIENT

    Active Ingredients

    Mineral Oil 14%

    Petrolatum 74.9%

    Phenylephrine HCL 0.25%

  • PURPOSE

    Purpose

    Protectant

    Protectant

    Vasoconstrictor

  • INDICATIONS & USAGE

    Uses

    • For the temporary relief of local anorectal burning and discomfort associated with hemmorrhoids, anorectal disorders, inflamed hemorrhoidal tissues or piles.
  • WARNINGS

    Warnings

    For external use only.

  • STOP USE

    • Stop use and ask a doctorif condition worsens, or if symptoms persist for more than 7 days or clean-up and occur again within a few days.
    • Do not exceed the recommended daily dosage unless directed by a doctor.
    • In case of bleeding, consult a doctor promptly.
    • Certain persons can develop allergic reactions to 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.
    • If you are pregnant, do not use this product without first consulting a doctor.
  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.

    If ingested seek medical attention immediately or contact a Poison Control Center right away.

  • DOSAGE & ADMINISTRATION

    Directions

    • Cleanse the affected area with mild soap and warm water, rinse thoroughly.
    • Dry by patting or blotting with toilet tissue or soft cloth before applying this product.
    • Cover the entire affected area with a thin layer 1 to 3 times daily.
    • Children under 12 years of age need to consult a doctor before using this product.
  • SPL UNCLASSIFIED SECTION

    Other Information

    • Store at 20ºC to 25ºC (68ºF to 77ºF)
    • Lot No. & Exp. Date: see crimp of tube.
  • INACTIVE INGREDIENT

    Inactive Ingredients

    benzoic acid, butylated hydroxyanisole, glycerin, lanolin, lanolin alcohol, methylparaben, paraffin, propylparaben, tocopherol acetate, yellow wax.

  • PRINCIPAL DISPLAY PANEL

    PRINCIPAL DISPLAY PANEL

    Hemorrhoid Anesthetic Ointment

    NET WT. 1 OZ. (28 g)

    image of package label

  • INGREDIENTS AND APPEARANCE
    HEMORRHOID ANESTHETIC 
    mineral oil, petrolatum, phenylephrine hcl ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52000-057
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MINERAL OIL (UNII: T5L8T28FGP) (MINERAL OIL - UNII:T5L8T28FGP) MINERAL OIL0.14 g  in 1 g
    PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U) PETROLATUM0.749 g  in 1 g
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE0.0025 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    BENZOIC ACID (UNII: 8SKN0B0MIM)  
    BUTYLATED HYDROXYANISOLE (UNII: REK4960K2U)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    LANOLIN (UNII: 7EV65EAW6H)  
    LANOLIN ALCOHOLS (UNII: 884C3FA9HE)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PARAFFIN (UNII: I9O0E3H2ZE)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    YELLOW WAX (UNII: 2ZA36H0S2V)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:52000-057-021 in 1 CARTON12/09/2020
    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 DrugM01612/09/2020
    Labeler - Universal Distribution Center LLC (019180459)
    Registrant - Savvy Care & Cosmetics Pvt. Ltd. (915039748)
    Establishment
    NameAddressID/FEIBusiness Operations
    Savvy Care & Cosmetics Pvt. Ltd.915039748manufacture(52000-057)