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Family Care Hemorrhoidal (United Exchange Corp)

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OINTMENT 1 TUBE in 1 CARTON (65923-003-20) > 20 g in 1 TUBE Label Information

Complete Family Care Hemorrhoidal Information

  • ACTIVE INGREDIENT

    Active ingredients                                                        Purpose

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

    Petrolatum 74.9%.....................................................Protectant

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


  • PURPOSE

    Uses

    • helps relieve the local itching and discomfort associated with hemorrhoids
    • temporarily shrinks hemorrhoidal tissue and relieve 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 use only / 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 a 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 unless directed by a doctor


  • STOP USE

    Stop use and ask a doctor if

    • bleeding occurs
    • condition gets worse or does not get better within 7 days

  • 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 ointment
    • when first opening tube, remove foil seal
    • apply externally to the affected area up to 4 times daily, especially at night, in the morning or after each bowel movement
    • for intraectal use: remove protective cover from applicator and attach applicator to tube
    • lubricate applicator well, then gently insert applicator into the rectum
    • thoroughly clean applicator and replace protective cover after each use
    • also apply ointment to external area
    • regular use provides continual therapy for relief of symptoms

  • STORAGE AND HANDLING

    Other information

    • store at 20° C to 25°C (68° to 77°F)
    • Lot No. and Exp. Date: see box or see crimp of tube

  • INACTIVE INGREDIENT

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


  • DOSAGE & ADMINISTRATION

    Distributed by:

    United Exchange Corp

    17211 Valley View Ave.

    Cerritos, CA 90703 USA

    Made in Korea


  • INGREDIENTS AND APPEARANCE
    FAMILY CARE HEMORRHOIDAL  
    mineral oil ointment
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:65923-003
    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 100 g
    PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U) PETROLATUM 749 mg  in 100 g
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE 2.5 mg  in 100 g
    Inactive Ingredients
    Ingredient Name Strength
    GLYCERIN (UNII: PDC6A3C0OX)  
    LANOLIN (UNII: 7EV65EAW6H)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
    THYME OIL (UNII: 2UK410MY6B)  
    ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    WATER (UNII: 059QF0KO0R)  
    WHITE WAX (UNII: 7G1J5DA97F)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:65923-003-20 1 in 1 CARTON
    1 20 g in 1 TUBE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part346 11/24/2014
    Labeler - United Exchange Corp (840130579)