Label: PREFERRED PLUS HEMORRHOIDAL- phenylephrine hydrochloride and witch hazel cream

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

NOTE: Most over the counter (OTC) are not reviewed and approved by the 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 03/14

If you are a consumer or patient please visit this version.

  • SPL UNCLASSIFIED SECTION

    Drug Facts

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  • Active ingredients

    Phenylephrine hydrochloride 0.25%

    Witch hazel 50.0%

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  • PURPOSE

    Vasoconstrictor

    Astringent

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  • Uses

    • temporarily relieves irritation and burning
    • helps relieve the local itching and discomfort associated with hemorrhoids
    • temporarily shrinks hemorrhoidal tissue
    • aids in protecting irritated anorectal areas
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  • Warnings

    For external use only

    Ask a doctor before use if you have

    • heart disease
    • high blood pressure
    • diabetes
    • thyroid disease
    • trouble urinating due to an enlarged prostate gland

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

    When using this product

    • do not exceed the recommended daily dosage
    • do not put this product into the rectum by using fingers or any mechanical device or applicator

    Stop use and ask a doctor if

    • bleeding occur
    • condition gets worse or does not Improve within 7 days

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

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

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  • Directions

    • Adults: when practical, cleanse and gently dry the affected area by patting or blotting with an appropriate cleansing tissue or soft cloth before applying gel
    • when first opening the tube, puncture foil seal with top end of cap
    • apply externally to the affected area up to 4 times daily, especially at night, in the morning or after each bowel movement
    • Children under 12 years of age: ask a doctor
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  • Other information

    • store at 20°-25°C (68°-77°F)
    • for lot number and expiration date, see crimp of tube or see box
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  • Inactive ingredients

    • aloe barbadensis leaf juice, disodium EDTA, hydroxyethylcellulose, methylparaben, polysorbate 80, propylene glycol, propylparaben, purified water, sodium citrate, tocopheryl acetate (Vitamin E)
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  • Principal Display Panel - 1 oz Carton Label

    TAMPER-EVIDENT: Do not use if printed "safety sealed" overwrap is broken or missing.

    NDC 61715-093-01

    Preferred Plus Pharmacy®

    HEMORRHOIDAL

    Cooling Gel with aloe

    *Compare to the active ingredients in PREPARATION H® Cooling Gel

    Fast Cooling Relief

    • Clean, Non-Greasy Formula with No Unpleasant Scent
    • Prompt Cooling Relief from Painful Burning and Itching
    • Shrinks Swollen Hemorrhoidal Tissue
    • Relieves External Discomfort

    SATISFACTION GUARANTEED

    Preferred Plus Pharmacy®

    NET WT 1 OZ (28 g)

    Principal Display Panel - 1 oz Carton Label
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  • INGREDIENTS AND APPEARANCE
    PREFERRED PLUS HEMORRHOIDAL 
    phenylephrine hydrochloride, witch hazel cream
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:61715-093
    Route of Administration RECTAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    phenylephrine hydrochloride (phenylephrine) phenylephrine hydrochloride 2.5 mg  in 1 L
    witch hazel (witch hazel) witch hazel 500 mg  in 1 L
    Inactive Ingredients
    Ingredient Name Strength
    aloe vera leaf  
    edetate disodium  
    hydroxyethyl cellulose (100 mpa.s at 2%)  
    methylparaben  
    polysorbate 80  
    propylene glycol  
    propylparaben  
    water  
    sodium citrate  
    .alpha.-tocopherol acetate  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:61715-093-01 1 in 1 CARTON
    1 0.028 L in 1 TUBE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part346 03/28/2014
    Labeler - Kinray Inc. (012574513)
    Establishment
    Name Address ID/FEI Business Operations
    Tropical Products 157469086 MANUFACTURE(61715-093)
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