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QUALITY CHOICE HEMORRHOIDAL (CHAIN DRUG MARKETING ASSOCIATION INC)

Available Formats

Dosage Form Package Information Links
OINTMENT 1 TUBE in 1 CARTON (63868-951-57) > 57 g in 1 TUBE Label Information

Complete QUALITY CHOICE HEMORRHOIDAL Information

  • ACTIVE INGREDIENT

    Active ingredients                                                              Purpose

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

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

    Phenylephrine HCL 0.25% .................................................Vasoconstrictor

    Shark liver oil 3.0% ...........................................................Protectant


  • 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

  • WARNINGS

    Warnings

    For external and/or intrarectal use only


  • 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

  • ASK DOCTOR/PHARMACIST

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


  • WHEN USING

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


  • 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


  • PREGNANCY OR BREAST FEEDING

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


  • 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.


  • 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 form 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

  • STORAGE AND HANDLING

    Other information

    Store at 20o to 25oC (68o to 77oF)


  • INACTIVE INGREDIENT

    Inactive ingredients

    benzoic acid, BHA, BHT, methylparaben, paraffin, propylparaben, thyme oil, glyceryl stearate, glycerin, absorb refined lanoline, purified water


  • DOSAGE & ADMINISTRATION

    DISTRIBUTED BY QUALITY CHOICE

    NOVI, MI 48376-0995

    QC 95128

    www.qualitychoice.com

    Made in Korea


  • PRINCIPAL DISPLAY PANEL

    image of carton labelEnter section text here


  • INGREDIENTS AND APPEARANCE
    QUALITY CHOICE HEMORRHOIDAL 
    mineral oil, petrolatum, phenylephrine hcl, shark liver oil ointment
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:63868-951
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    MINERAL OIL (UNII: T5L8T28FGP) (MINERAL OIL - UNII:T5L8T28FGP) MINERAL OIL 140 mg  in 1 g
    PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U) PETROLATUM 719 mg  in 1 g
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE 2.5 mg  in 1 g
    SHARK LIVER OIL (UNII: 4B24275HEU) (SHARK LIVER OIL - UNII:4B24275HEU) SHARK LIVER OIL 30 mg  in 1 g
    Inactive Ingredients
    Ingredient Name Strength
    BENZOIC ACID (UNII: 8SKN0B0MIM)  
    BUTYLATED HYDROXYANISOLE (UNII: REK4960K2U)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PARAFFIN (UNII: I9O0E3H2ZE)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    THYME OIL (UNII: 2UK410MY6B)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:63868-951-57 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 03/01/2012
    Labeler - CHAIN DRUG MARKETING ASSOCIATION INC (011920774)