BUDPAK HEMORRHOID ANESTHETIC (MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCL) OINTMENT [BUDPAK INC. ]

BUDPAK HEMORRHOID ANESTHETIC (MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCL) OINTMENT [BUDPAK INC. ]
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NDC 27293-026-01, 27293-026-28
Set ID 8cb751f8-9a7d-4f2b-94b8-7f40ab2c23a6
Category HUMAN OTC DRUG LABEL
Packager Budpak Inc.
Generic Name
Product Class alpha-1 Adrenergic Agonist
Product Number
Application Number PART346
  • 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 doctor if condition worsens, or if symptoms persist for more than 7 days or clear-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 room temperature 20ºC to 25ºC (68ºF to 77ºF)
    • Lot No. & Exp. Date: see crimp of tube.
  • INACTIVE INGREDIENT

    Inactive Ingredients

    benzoic acid, butylated hydroxyanisole, corn oil, glycerin, lanolin, lanolin alcohol, methylparaben, mineral oil, paraffin, propylparaben, shark liver oil, thyme oil, tocopherol acetate, yellow wax, purified water.

  • SPL UNCLASSIFIED SECTION

    PRINCIPAL DISPLAY PANEL

    Budpak Hemorrhoid Anesthetic Ointment

    Mineral Oil 14%

    Petrolatum 74.9%

    Phenylephrine HCL 0.25%

    NET WT 1 OZ (28 g)

  • PRINCIPAL DISPLAY PANEL

    image of package label

  • INGREDIENTS AND APPEARANCE
    BUDPAK HEMORRHOID ANESTHETIC 
    mineral oil, petrolatum, phenylephrine hcl ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:27293-026
    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)  
    CORN OIL (UNII: 8470G57WFM)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    LANOLIN (UNII: 7EV65EAW6H)  
    LANOLIN ALCOHOLS (UNII: 884C3FA9HE)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PARAFFIN (UNII: I9O0E3H2ZE)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    SHARK LIVER OIL (UNII: 4B24275HEU)  
    THYME OIL (UNII: 2UK410MY6B)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    YELLOW WAX (UNII: 2ZA36H0S2V)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:27293-026-011 in 1 BOX
    1NDC:27293-026-2828 g in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34606/10/2013
    Labeler - Budpak Inc. (183224849)
    Registrant - Anicare Pharmaceuticals Pvt. Ltd (916837425)
    Establishment
    NameAddressID/FEIBusiness Operations
    Anicare Pharmaceuticals Pvt. Ltd916837425manufacture(27293-026)

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