QUALITY CHOICE HEMORRHOIDAL (MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCL, SHARK LIVER OIL) OINTMENT [CHAIN DRUG MARKETING ASSOCIATION INC]

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  • QUALITY CHOICE HEMORRHOIDAL (MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCL, SHARK LIVER OIL) OINTMENT [CHAIN DRUG MARKETING ASSOCIATION INC]

QUALITY CHOICE HEMORRHOIDAL (MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCL, SHARK LIVER OIL) OINTMENT [CHAIN DRUG MARKETING ASSOCIATION INC]
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NDC 63868-951-57
Set ID 8db1cff7-337f-4ed3-a4de-2d392eb908c6
Category HUMAN OTC DRUG LABEL
Packager CHAIN DRUG MARKETING ASSOCIATION INC
Generic Name
Product Class alpha-1 Adrenergic Agonist
Product Number
Application Number PART346
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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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