FREDS HEMORRHOIDAL (MINERAL OIL, PETROLATUM, PHENYLEPHRINE HYDROCHLORIDE) CREAM [FREDS, INC]

FREDS HEMORRHOIDAL (MINERAL OIL, PETROLATUM, PHENYLEPHRINE HYDROCHLORIDE) CREAM [FREDS, INC]
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NDC 55315-336-57
Set ID c940fab1-b842-4ba7-af38-87faa33346c4
Category HUMAN OTC DRUG LABEL
Packager Freds, Inc
Generic Name
Product Class alpha-1 Adrenergic Agonist
Product Number
Application Number PART346
  • ACTIVE INGREDIENT

    Active Ingredients                                                   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 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

  • 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 from 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 20° to 25°C (68° to 77°F)

  • INACTIVE INGREDIENT

    Inactive Ingredients

    glycerin, lanolin, methylparaben, proplyparaben, steryl alcohol, thyme oil, tocopherol acetate, water, white wax

  • DOSAGE & ADMINISTRATION

    DISTRIBUTED BY:

    FRED'S, INC.

    4300 NEW GETWELL RD.

    MEMPHIS, TN 38118 USA

  • PRINCIPAL DISPLAY PANEL

    image description

  • INGREDIENTS AND APPEARANCE
    FREDS HEMORRHOIDAL 
    mineral oil, petrolatum, phenylephrine hydrochloride cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55315-336
    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) PETROLATUM749 mg  in 1 g
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE2.5 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    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 CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55315-336-571 in 1 BOX10/06/2016
    157 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34601/03/2014
    Labeler - Freds, Inc (005866116)

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