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  5. Label Information: Hemorrhoidal Cooling

FDA Label for Hemorrhoidal Cooling

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENT
    2. PURPOSE
    3. USE
    4. WARNINGS
    5. DO NOT USE
    6. ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOU ARE
    7. WHEN USING THIS PRODUCT
    8. STOP USE AND ASK A DOCTOR IF
    9. IF PREGNANT OR BREAST-FEEDING
    10. KEEP OUT OF REACH OF CHILDREN.
    11. DIRECTIONS
    12. OTHER INFORMATION
    13. INACTIVE INGREDIENTS
    14. QUESTIONS OR COMMENTS?
    15. PHARMACIST SURVERY
    16. ADVERSE REACTIONS SECTION
    17. PRINCIPAL DISPLAY PANEL

Hemorrhoidal Cooling Product Label

The following document was submitted to the FDA by the labeler of this product Walgreens. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Active Ingredient



Phenylephrine HCl 0.25%

Witch hazel 50%


Purpose



Vasoconstrictor

Astringent


Use



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

Warnings



For external use only


Do Not Use



this product if you have heart disease, high blood pressure, thyroid disease, diabetes, or difficulty in urination due to enlargement of the prostate gland unless directed by a doctor


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 unless directed by a doctor
  • do not put this product into the rectum by using fingers or any mechanical device or applicator
  • in case of bleeding, consult a doctor promptly

Stop Use And Ask A Doctor If



condition worsens or does not improve with in 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.


Directions



  • adults: when practial, cleanse the affected area by patting or blotting with appropriate cleansing pad.  Gently dry by patting or blotting with toilet tissue or a soft cloth before appliacation of this product
  • when you first opening the tube, remove foil under cap
  • apply externally to affected area up to 4 times daily
  • children under 12 years of age: ask a doctor


Other Information



store between 15° - 30° C (58° - 86 ° F)


Inactive Ingredients



Aloe barbadensis leaf juice, benzophenone-4, disodium EDTA, hydroxyethylcellulose, methylparaben, propylene glycol, propylparaben, sodium citrate, water


Questions Or Comments?



Call 1-888-593-0593


Pharmacist Survery



Walgreens Pharmacist Survey Study, November 2014

This product is not manufactured or distributed by Pfizer Consumer Health care, distributor of Preparation H Hemorrhidal Cooling Gel.


Adverse Reactions Section



DISTRIBUTED BY: WALGREEN CO.

200 WILMOT RD., DEERFIELD, IL 60015

WALLGREENS 100% SATISFACTION GUARANTEED

walgreens.com

175.000/175AA


Principal Display Panel



Well at

Walgreens

Hemorrhoidal Cooling Gel

Quick, Cooling Relief/With Soothing Aloe

  • Clear, non-greasy formula, with no unpleasant scent
  • Temporarily shrinks swollen hemorrhoidal tissue
  • Quick, cooling relief from burning & itching
  • Temporarily relieves irritation

    • Compare to Preparathion H Hemorrhoidal Cooling Gel active ingredients

    NET WT 0.9 OZ (25.5 g)

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* Please review the disclaimer below.