WINCO HEMORRHOIDAL (MINERAL OIL, PETROLATUM, AND PHENYLEPHRINE HYDROCHLORIDE) CREAM [WINCO FOODS, LLC]

WINCO HEMORRHOIDAL (MINERAL OIL, PETROLATUM, AND PHENYLEPHRINE HYDROCHLORIDE) CREAM [WINCO FOODS, LLC]
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NDC 67091-278-57
Set ID 04ca3ef1-fc6b-4683-b236-a75afc031fb5
Category HUMAN OTC DRUG LABEL
Packager Winco Foods, LLC
Generic Name
Product Class alpha-1 Adrenergic Agonist
Product Number
Application Number PART346
  • ACTIVE INGREDIENT

    Active Ingredients (in each gram)                                                                       Purpose

    Mineral oil 14%  ---------------------------------------------------------------------      Protectant

    Petrolatum 74.9%-------------------------------------------------------------------       Protectant

    Phenylephrine hydrochloride 0.25% -----------------------------------------------       Vasoconstrictor

  • 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 or anorectal discomforts
    • temporarily portects the inflamed, irritated anorectal surface to help make bowel movements less painful
  • WARNINGS

    For External use only and/or intrarectal use only

    Children under 12 years of age:ask a doctor

  • ASK DOCTOR

    Ask a doctor before use if you have

    heart disease, high blood pressure, thyroid disease, diabetes, difficulty urinating due to enlargement of the prostate gland

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

  • WHEN USING

    When using this product do not exceed the recommended daily dosage unless directly by a doctor

  • DO NOT USE

    Stop use and ask a doctor if

    bleeding occurs, condition worsens or does not improve within 7 days, introduction of applicator into the rectum causes additional pain

  • PREGNANCY OR BREAST FEEDING

    If pregnant or breast-feeding, ask a health professional before use

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of childern.

    If swallowed, get medical help or contact a Poison Control Center right away.

  • INDICATIONS & USAGE

    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 to the affected area up to 4 times daily, especially at night, in the morning or after each bowel movement

    Intrarectal use: remove cover from applicator, attach applicator to tube, lubricate applicator well and gently insert applicator into the rectum

    thoroughly cleanse applicator after each use and replace cover

    also apply ointment to external area

    regular use provides continual therapy for relief of symptoms

  • STORAGE AND HANDLING

    Other information:

    • store between 20° yp 25°C (68° to 77°F)
    • Lot No. & Exp. Date:see box or see crimp of tube
  • INACTIVE INGREDIENT

    Inactive ingredients

    ethanol, glycerin, lanolin, methylparaben, polyborbate 80, propylparaben, stearyl alcohol, thyme oil, tocopherol acetate, water, white wax

  • DOSAGE & ADMINISTRATION

    DISTRIBUTED BY:

    WINCO FOODS, LLC,

    BOISE, ID 83704

    MADE IN KOREA

  • PRINCIPAL DISPLAY PANEL

    image description

  • INGREDIENTS AND APPEARANCE
    WINCO HEMORRHOIDAL 
    mineral oil, petrolatum, and phenylephrine hydrochloride cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67091-278
    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
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE2.5 mg  in 1 g
    PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U) PETROLATUM749 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    GLYCERIN (UNII: PDC6A3C0OX)  
    LANOLIN (UNII: 7EV65EAW6H)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
    THYME OIL (UNII: 2UK410MY6B)  
    ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    WHITE WAX (UNII: 7G1J5DA97F)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:67091-278-571 in 1 CARTON
    157 g in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34601/29/2015
    Labeler - Winco Foods, LLC (056098817)

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