Rexall Maximum Strength Hemorrhoidal
FDA Label NDC 55910-406

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, Inc. for the product Rexall Maximum Strength Hemorrhoidal (NDC 55910-406). 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 otc - active ingredient, otc - purpose, indications & usage, warnings, otc - keep out of reach of children, dosage & administration, other, inactive ingredient, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Otc - Active Ingredient

Active ingredients  
Glycerin 14.4%
Petrolatum 15%
Phenylephrine Hydrochloride 0.25%
Pramoxine HCl 1%

Otc - Purpose

Purpose

Protectant
Protectant
Vasoconstrictor
Local anesthetic

Indications & Usage

Uses

  • helps relieve the local itching and discomfort associated with hemorrhoids
  • temporarily shrinks hemorrhoidal tissue
  • temporary relieves burning
  • aid in protecting irritated anorectal areas

Warnings

Warnings

For external use only.

Ask a doctor before use if you have

  • heart disease
  • high blood pressure 
  • diabetes 
  • thyroid disease
  • trouble urinating due to an enlarged prostate gland

    • 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 rectum by using fingers or any mechanical device or applicator

      • Stop use and ask a doctor if

      • bleeding occurs
      • condition gets worse or does not improve within 7 days

        • 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.

Dosage & Administration

Directions

  • Adults: when practical, cleanse  and gently dry the affected area by patting or blotting with an appropriate cleansing tissue or soft cloth before applying.
  • 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 of age: ask a doctor

Other

Other information

  • store at 20°- 25°C (68°- 77°F)
  • for lot number and expiration date, see crimp of tube or see box

Inactive Ingredient

Inactive ingredients

aloe barbadensis leaf, cetearyl alcohol, cetyl alcohol, glycerol monostearate,  mineral oil, peg 40 castor oil, propylene glycol, purified water, 
stearyl alcohol, tocopheryl acetate (Vitamin E).

Package Label.Principal Display Panel

PRINCIPAL DISPLAY PANEL

REXALL MAXIMUM STRENGTH HEMORRHOIDAL

NET WT 1 OZ (28 g)

Label Of Rexall (Rexall Hemorrhoidal)

Label Of Rexall (Rexall Hemorrhoidal)

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