Label: MAJOR PREP HEMORRHOIDAL- mineral oil, petrolatum and phenylephrine hydrochloride ointment

  • 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 06/13

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  • ACTIVE INGREDIENT

    Active ingredients                                                               Purpose

    Mineral oil 14%................................................................Protectant

    Petrolatum 71.9%............................................................Protectant

    Phenylephrine HCl 0.25%..........................................Vasoconstrictor

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  • PURPOSE

    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

    Warnings For external and/or intrarectal use only

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  • ASK DOCTOR

    Ask a doctor before use if you have

    • heart disease
    • high blood pressure
    • thyroid disease
    • diabetes
    • trouble urinating due to an enlarged prostate gland
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  • ASK DOCTOR/PHARMACIST

    Ask a doctor or a pharmacist before use if you are now taking a prescription drug for high blood pressure or depression

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  • WHEN USING

    When using this product do not use more than the recommended daily dosage

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  • STOP USE

    Stop use and ask a doctor if

    • bleeding occurs
    • condition gets worse or does not get better within 7 days
    • introduction of the applicator into the rectum causes additional pain
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  • PREGNANCY OR BREAST FEEDING

    If pregnant or breast-feeding, ask a physician before use.

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  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

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  • INDICATIONS & USAGE

    Directions

    • children under 12 years of age: ask a doctor
    • 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
    • when first opening tube, remove foil seal
    • for intrarectal use: remove protective cover from applicator and attach to tube
    • lubricate applicator well, then gently insert applicator into the rectum
    • thoroughly clean applicator and replace protective cover after each use
    • apply externally to the affected area up to 4 times daily, especially at night, in the morning or after each bowel movement
    • also apply ointment to external area
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  • STORAGE AND HANDLING

    Other information store at 20° to 25°C (68° to 77°F)

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  • INACTIVE INGREDIENT

    Inactive ingredients glycerin, lanolin, methylparaben, propylparaben, stearyl alcohol, thyme oil, tocopherol acetate, water, white wax

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  • DOSAGE & ADMINISTRATION

    Distributed By

    Major Pharmaceuticals

    31778 Enterprise Drive

    Livonia, MI 48150

    Made in Korea

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  • INGREDIENTS AND APPEARANCE
    MAJOR PREP HEMORRHOIDAL 
    mineral oil, petrolatum, phenylephrine hydrochloride ointment
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:0904-6319
    Route of Administration TOPICAL, RECTAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    MINERAL OIL (MINERAL OIL) MINERAL OIL 140 mg  in 1 g
    PETROLATUM (PETROLATUM) PETROLATUM 719 mg  in 1 g
    PHENYLEPHRINE HYDROCHLORIDE (PHENYLEPHRINE) PHENYLEPHRINE HYDROCHLORIDE 2.5 mg  in 1 g
    Inactive Ingredients
    Ingredient Name Strength
    GLYCERIN  
    LANOLIN  
    METHYLPARABEN  
    PROPYLPARABEN  
    STEARYL ALCOHOL  
    THYME OIL  
    ALPHA-TOCOPHEROL ACETATE  
    WATER  
    WHITE WAX  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0904-6319-02 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 06/30/2013
    Labeler - Major Pharmaceuticals (191427277)
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