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  5. Label Information: Hemorrhoidal Cooling Gel

FDA Label for Hemorrhoidal Cooling Gel

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENT
    2. PURPOSE
    3. USES
    4. WARNINGS
    5. ASK A DOCTOR BEFORE USE IF YOU HAVE
    6. ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOU ARE
    7. WHEN USING THIS PRODUCT
    8. STOP USE AND ASK A DOCTOR
    9. IF PREGNANT OR BREASTFEEDING,
    10. KEEP OUT OF REACH OF CHILDREN
    11. DIRECTIONS
    12. OTHER
    13. OTHER INFORMATION
    14. INACTIVE INGREDIENTS
    15. OTC - QUESTIONS
    16. PACKAGE INFORMATION

Hemorrhoidal Cooling Gel Product Label

The following document was submitted to the FDA by the labeler of this product Amerisource Bergen. 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 HCI, 0.25%
Witch Hazel, 50%


Purpose



Vasoconstrictor
Astringent


Uses



  • Helps relieve the local itching and discomfort associated with hemorrhoids
  • Temporary relief of itching and burning
  • Temporarily shrinks hemorrhoidal tissue
  • Aids in protecting irritated anorectal areas

Warnings



For external use only.



Ask A Doctor Before Use If You Have



  • heart disease
  • thyroid disease
  • high blood pressure
  • diabetes
  • difficulty in urination due to enlargement of the prostate

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 into the rectum using fingers or any mechanical device or applicator

Stop Use And Ask A Doctor



  • if bleeding occurs
  • condition worsens or does not improve within 7 days

If Pregnant Or Breastfeeding,



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 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 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: ask a doctor.

Other





Other Information



Store at room temperature: 20° - 25° C (68° - 77° F)

Inactive Ingredients



Aloe barbadensis gel, benzophenone-4, edetate disodium, hydroxyethylcellulose, methylparaben, polysorbate 80, propylene glycol, propylparaben, sodium citrate, vitamin E, water

Otc - Questions





Package Information



GOOD NEIGHBOR PHARMACY

NDC 24385-421-06

HEMORRHOIDAL
Cooling Gel
with Vitamin E and Aloe

Fast cooling relief from painful burning and itching

Net Wt. 0.9 oz. (26 g)

Fast cooling relief

  • Clear, non-greasy formula with no unpleasant scent
  • Prompt cooling relief from painful burning and itching
  • Shrinks swollen hemorrhoidal tissue 
  • Relieves external discomfort

    • *Compare to active ingredients in Preparation H® Cooling Gel


    FOR YOUR SAFETY, TUBE IS SEALED. DO NOT USE IF TUBE SEAL UNDER CAP IS BROKEN OR MISSING.

    *This product is not manufactured or distributed by Wyeth Consumer Healthcare, Inc., owner of the registered trademark Preparation H®.

    Distributed By
    AmerisourceBergen
    Valley Forge, PA 19482-0959

    Visit us at www.myGNP.com


    carton - 33 50048GN C A0806 1

    carton - 33 50048GN C A0806 1


* Please review the disclaimer below.