SUNMARK HEMORRHOIDAL (MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCL) OINTMENT [MCKESSON]

SUNMARK HEMORRHOIDAL (MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCL) OINTMENT [MCKESSON]
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NDC 49348-198-78
Set ID 96272510-a5ac-45eb-b693-4ccd1df85405
Category HUMAN OTC DRUG LABEL
Packager Strategic Sourcing Services LLC
Generic Name
Product Class alpha-1 Adrenergic Agonist
Product Number
Application Number PART346
  • Active ingredients

    Mineral oil 14%

    Petrolatum 74.9%

    Phenylephrine HCl 0.25%

  • Purposes

    Protectant

    Vasoconstrictor

  • Uses

    helps relieve the local itching and discomfort associated with hemorrhoids
    temporarily shrinks hemorrhoidal tissue and relieves burning
    temporarily provides a coating for relief of anorectal discomforts
    temporarily protects the inflamed, irritated anorectal surface to help make bowel movements less painful
  • Warnings

    For external and/or intrarectal use only

    Ask a doctor before use if you have

    heart disease
    high blood pressure
    thyroid disease
    diabetes
    difficulty in urination due to enlargement of the prostate gland

    Ask a doctor or pharmacist before use if you are

    presently taking a prescription drug for high blood pressure or depression.

    When using this product

    do not exceed the recommended daily dosage unless directed by a doctor

    Stop use and ask a doctor if

    bleeding occurs
    condition worsens or does not improve within 7 days
    introduction of applicator into the rectum causes additional pain

    If pregnant 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. (1-800-222-1222)

  • Directions

    adults: when practical, cleanse the affected area by patting or blotting with an appropriate cleansing wipe. Gently dry by patting or blotting with a tissue or a soft cloth before applying ointment.
    when first opening the tube, puncture foil seal with top end of cap
    apply to the affected area up to 4 times daily, especially at night, in the morning or after each bowel movement
    intrarectal use: remove cover from applicator, attach applicator to tube, lubricate applicator well and gently insert applicator into the rectum, thoroughly cleanse applicator after each use and replace cover
    also apply ointment to external area
    regular use provides continual therapy for relief of symptoms
    children under 12 years of age: ask a doctor

    Other information

    store at 20-25°C (68-77°F)
  • Inactive ingredients

    benzoic acid, butylated hydroxyanisole, corn oil, glycerin, lanolin, lanolin alcohols, methylparaben, mineral oil, paraffin, propylparaben, purified water, thymus vulgaris (thyme) oil, tocopheryl acetate, white wax

    Questions or comments?

    1-800-719-9260

  • Package/Label Principal Display Panel

    COMPARE TO PREPARATION H® HEMORRHOIDAL OINTMENT ACTIVE INGREDIENTS

    hemorrhoidal ointment

    Shrinks swollen hemorrhoidal tissue

    Relieves internal and external discomfort

    Prompt, soothing relief from painful burning, itching and discomfort

    MEDICATED FORMULA

    NET WT 2 OZ (57 g)

    hemorrhoidal ointment carton
  • INGREDIENTS AND APPEARANCE
    SUNMARK HEMORRHOIDAL 
    mineral oil, petrolatum, phenylephrine hcl ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49348-198
    Route of AdministrationRECTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MINERAL OIL (UNII: T5L8T28FGP) (MINERAL OIL - UNII:T5L8T28FGP) MINERAL OIL14 g  in 100 g
    PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U) PETROLATUM74.9 g  in 100 g
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE.25 g  in 100 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)  
    WATER (UNII: 059QF0KO0R)  
    THYME OIL (UNII: 2UK410MY6B)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    WHITE WAX (UNII: 7G1J5DA97F)  
    Product Characteristics
    ColorYELLOW (light) Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49348-198-781 in 1 CARTON07/25/2016
    157 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34607/25/2016
    Labeler - Strategic Sourcing Services LLC (116956644)

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