Hemorrhoidal Cooling Gel
FDA Label NDC 24385-421

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Amerisource Bergen for the product Hemorrhoidal Cooling Gel (NDC 24385-421). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredient, purpose, uses, warnings, ask a doctor before use if you have, ask a doctor or pharmacist before use if you are, when using this product, stop use and ask a doctor, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

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)

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