Label: SMART SENSE HEMORRHOIDAL- mineral oil, petrolatum and phenylephrine hydrochloride ointment 

  • Label RSS
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

NOTE: Most over the counter (OTC) are not reviewed and approved by the FDA. However, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated 02/13

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

  • Active ingredients

    Mineral oil 14%

    Petrolatum 71.9%

    Phenylephrine HCl 0.25%

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  • Purposes

    Protectant

    Vasoconstrictor

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  • 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
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  • Warnings

    For external and/or intrarectal use only

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  • 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
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  • Ask a doctor or pharmacist before use if you are

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

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  • When using this product

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

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  • 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
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  • If pregnant or breast-feeding,

    ask a health professional before use.

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  • Keep out of reach of children.

    If swallowed, get medical help or contact a Poison Control Center right away. (1-800-222-1222)

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  • 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
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  • Other information

    store at 20-25 oC (68-77 oF)
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  • Inactive ingredients

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

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  • Questions or comments?

    1-800-719-9260

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  • Package/Label Principal Display Panel

    Compare to the active ingredients of Preparation H® Ointment

    HEMORRHOIDAL OINTMENT

    Prevents Further Irritation

    Prompt, Soothing Relief from Painful Burning, Itching and Discomfort

    Shrinks Swollen Hemorrhoidal Tissue

    Protects irritated tissue

    Relieves Internal and External Discomfort

    Hemorrhoidal Ointment Carton Image 1
    Hemorrhoidal Ointment Carton Image 2
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  • INGREDIENTS AND APPEARANCE
    SMART SENSE HEMORRHOIDAL 
    mineral oil, petrolatum, phenylephrine hcl ointment
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:49738-678
    Route of Administration RECTAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    MINERAL OIL (MINERAL OIL) MINERAL OIL 140.000 mg  in 100 g
    PETROLATUM (PETROLATUM) PETROLATUM 719.000 mg  in 100 g
    PHENYLEPHRINE HYDROCHLORIDE (PHENYLEPHRINE) PHENYLEPHRINE HYDROCHLORIDE 2.500 mg  in 100 g
    Inactive Ingredients
    Ingredient Name Strength
    BENZOIC ACID  
    BUTYLATED HYDROXYANISOLE  
    CORN OIL  
    GLYCERIN  
    LANOLIN  
    LANOLIN ALCOHOLS  
    METHYLPARABEN  
    PARAFFIN  
    PROPYLPARABEN  
    WATER  
    SHARK LIVER OIL  
    THYME OIL  
    .ALPHA.-TOCOPHEROL ACETATE  
    WHITE WAX  
    Product Characteristics
    Color YELLOW Score     
    Shape Size
    Flavor Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:49738-678-16 1 in 1 CARTON
    1 57 g in 1 TUBE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part346 01/15/2013
    Labeler - Kmart Corporation (008965873)
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