Rexall Hemorrhoidal Cooling Gel
FDA Label NDC 55910-332

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Dolgencorp, Llc for the product Rexall Hemorrhoidal Cooling Gel (NDC 55910-332). 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 other, otc - purpose, uses, warnings, do not use this product, ask a doctor or pharmacist before use if you are, when using this product, stop use and ask a doctor if, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Other

Drug Facts

Otc - Purpose

Active ingredientsPurposes
Hamamelis virginiana (witch hazel) 50%Astringent
Phenylephrine hydrochloride 0.25%Vasoconstrictor

Uses

  • temporarily relieves anorectal itching and discomfort associated with hemorrhoids or anorectal disorders
  • temporarily reduces the swelling associated with irritation in hemorrhoids and other anorectal disorders
  • temporarily shrinks hemorrhoidal tissue
  • aids in protecting irritated anorectal areas
  • temporary relief of burning

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 recommended daily dosage unless directed by a doctor
  • do not put into rectum by using fingers or any mechanical device or applicator

Stop Use And Ask A Doctor If

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

Otc - Pregnancy Or Breast Feeding

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

Otc - Keep Out Of Reach Of Children

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away: 800-222-1222.

Directions

  • Adults
    • when practical, cleanse affected area by patting or blotting with appropriate cleansing wipe. Gently dry by patting or blotting with tissue or soft cloth before applying gel
    • apply externally to affected area up to 4 times daily or after each bowel movement
    • Children under 12 years old: Ask a doctor.

Other Information

  • Store at 15 to 30°C (59 to 86°F)
  • Tamper Evident: DO NOT USE IF SEAL ON TUBE IS BROKEN OR MISSING.

Inactive Ingredients

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

Principal Display Panel - 26 G Tube Carton

NDC 55910-332-24

Since 1903
Rexall®

CLEAR, NON-GREASY FORMULA

Hemorrhoidal Cooling Gel

Enriched
with
Aloe

  • Prompt cooling relief from painful burning & itching
  • Relieves external discomfort

    • NET WT 0.9 OZ (26 g)

    Principal Display Panel (26 g Tube Carton)

    Principal Display Panel (26 g Tube Carton)

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