Rexall Hemorrhoidal Cooling
FDA Label NDC 55910-416

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 Hemorrhoidal Cooling (NDC 55910-416). 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 ingredients, purpose, uses, warnings, otc - ask doctor, 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.

Label Section Quick Index

Active Ingredients

Phenylephrine Hydrochloride  0.25%
Witch Hazel   50%

Purpose

Vasoconstrictor
Astringent

Uses

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

Warnings

For external use only

Otc - Ask Doctor

Ask a doctor before use if you have

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

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 exceed the recommended daily dosage
  • do not put this product into the rectum by using fingers or any mechanical device or applicator

Otc - Stop Use

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.

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 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 of age: ask a doctor

Other Information

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

Inactive Ingredients

aloe barbadensis leaf juice, disodium EDTA, hydroxyethylcellulose, methylparaben, polysorbate 80, propylene glycol, propylparaben, purified water, sodium citrate, tocopheryl acetate (Vitamin E)

Principal Display Panel - 26 G Carton Label

REXALL HEMORRHOIDAL COOLING GEL

NET WT .9 OZ (26 g)

Label (Hemorrhoidal Cooling Gel)

Label (Hemorrhoidal Cooling Gel)

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