Label: QUALITY CHOICE HEMORRHOIDAL- mineral oil, petrolatum, phenylephrine hcl, shark liver oil ointment

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

DISCLAIMER: Most OTC drugs are not reviewed and approved by 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 March 1, 2012

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  • 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 TypeHUMAN OTC DRUGItem Code (Source)NDC:63868-951
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MINERAL OIL (UNII: T5L8T28FGP) (MINERAL OIL - UNII:T5L8T28FGP) MINERAL OIL140 mg  in 1 g
    PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U) PETROLATUM719 mg  in 1 g
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE2.5 mg  in 1 g
    SHARK LIVER OIL (UNII: 4B24275HEU) (SHARK LIVER OIL - UNII:4B24275HEU) SHARK LIVER OIL30 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    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 CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63868-951-571 in 1 CARTON
    157 g in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34603/01/2012
    Labeler - CHAIN DRUG MARKETING ASSOCIATION INC (011920774)
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