Label: HEMORRHOIDAL COOLING- phenylephrine hydrochloride and witch hazel gel

  • NDC Code(s): 55312-843-24
  • Packager: Western Family Foods Inc
  • 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 10/12

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

  • Active ingredient

    Phenylephrine HCl 0.25%

    Witch hazel 50.0%

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  • Purpose

    Vasoconstrictor

    Astringent

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  • Uses

    helps relieve the local itching and discomfort associated with hemorrhoids
    temporarily relieves irritation and burning
    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 occurs
    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)

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  • Inactive ingredients

    aloe vera gel, benzophenone-4, edetate disodium, hydroxyethylcellulose, methylparaben, polysorbate 80, propylene glycol, propylparaben, purified water, sodium citrate, vitamin E

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  • Package/Label Principal Display Panel

    HEMMORRDODIAL Cooling Gel

    Fast Cooling Relief

    Clear, Non-Greasy Formula with No Unpleasant Scent

    Prompt Cooling Relief from Painful Burning And Itching

    Shrinks Swollen Hemorrhoidal Tissues

    Relieves External Discomfort

    WITH VITMAIN E AND ALOE

    COMPARE TO THE ACTIVE INGREDIENTS OF PREPARATION H® COOLING GEL

    Hemorrhoidal Cooling Gel Carton Image
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  • INGREDIENTS AND APPEARANCE
    HEMORRHOIDAL COOLING 
    phenylephrine hcl, witch hazel gel
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:55312-843
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    PHENYLEPHRINE HYDROCHLORIDE (PHENYLEPHRINE) PHENYLEPHRINE HYDROCHLORIDE 0.25 g  in 100 g
    WITCH HAZEL (WITCH HAZEL) WITCH HAZEL 50.0 g  in 100 g
    Inactive Ingredients
    Ingredient Name Strength
    ALOE VERA LEAF  
    EDETATE DISODIUM  
    METHYLPARABEN  
    POLYSORBATE 80  
    PROPYLENE GLYCOL  
    PROPYLPARABEN  
    WATER  
    SODIUM CITRATE  
    .ALPHA.-TOCOPHEROL  
    SULISOBENZONE  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:55312-843-24 1 in 1 CARTON
    1 51 g in 1 TUBE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part346 09/24/2012
    Labeler - Western Family Foods Inc (192166072)
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