Rexall Hemorrhoidal
FDA Label NDC 55910-331

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Dolegencorp,llc for the product Rexall Hemorrhoidal (NDC 55910-331). 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, otc - do not use, otc - ask doctor/pharmacist, otc - when using, otc - stop use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Other

Drug Facts

Otc - Purpose

Active ingredientsPurpose
Glycerin 14.4%Anorectal (Hemorrhoidal) Cream
Petrolatum 15%Anorectal (Hemorrhoidal) Cream
Phenylephrine HCl 0.25%Anorectal (Hemorrhoidal) Cream
Pramoxine HCl 1%Anorectal (Hemorrhoidal) Cream

Uses

  • Temporarily relieves itching and discomfort associated with hemorrhoids.
  • Temporarily reduces swelling associated with irritation in hemorrhoids and other anorectal disorders.
  • Temporarily shrinks hemorrhoidal tissue
  • Temporarily forms a protective coating over inflamed tissues to help prevent dryness.
  • Temporarily protects the inflamed, irritated anorectal surface to help make bowel movements less painful

Warnings

Not for prolonged use.

Otc - Do Not Use

Do not use in the eyes or nose.

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.

Otc - Ask Doctor/Pharmacist

Ask a doctor or pharmacist before use if you are

  • presently taking a prescription drug for high blood pressure or depression

Otc - When Using

When using this product

  • do not apply to large areas of the body
  • do not exceed the recommended daily dosage unless directed by a doctor
  • do not use this product with an applicator if the introduction of the applicator into the rectum causes additional pain. Consult a doctor promptly.

Otc - Stop Use

Stop use and ask a physician if

  • bleeding occurs
  • the condition worsens or does not improve within 7 days
  • an allergic reaction develops
  • the symptom being treated does not subside or redness, irritation, swelling or pain develops, persists, or increases.

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 the affected area by patting or blotting with an appropriate cleansing pad. Gently dry by patting or blotting with a tissue or a soft cloth before applying cream
  • apply externally to the affected area up to 4 times daily or after each bowel movement
  • FOR INTRARECTAL USE: Remove the cover from the dispensing cap. Attach the dispensing cap to the tube. Lubricate the dispensing cap well, and then gently insert the dispensing cap into the rectum.
  • thoroughly cleanse dispensing cap after each use, and replace the cover
  • children under 12 years old: consult a physician

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, BHA, cetyl alcohol, citric acid, disodium EDTA, glyceryl stearate, laureth-23, methylparaben, mineral oil, panthenol, propyl gallate, propylene glycol, propylparaben, purified water, sodium benzoate, sodium carboxymethylcellulose, steareth-2, steareth-20, stearyl alcohol, tocopherol (vitamin E) acetate, xanthan gum

Principal Display Panel - 28 G Tube Carton

NDC 55910-331-24

Since 1903
Rexall
®

MAXIMUM STRENGTH

Hemorrhoidal Cream

  • Rapid, soothing pain relief from burning, itching and discomfort
  • Protects irritated tissue
  • NET WT 1 OZ (28 g)

* Please review the disclaimer below.