Rexall Hemorrhoidal Cooling
FDA Label NDC 55910-603

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Dollar General for the product Rexall Hemorrhoidal Cooling (NDC 55910-603). 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, otc - keep out of reach of children, indications & usage, warnings, dosage & administration, 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                                        PurposePhenylephrine hydrochloride 0.25%.............................VasoconstrictorWitch hazel 50.0%.....................................................Astringent

Otc - Purpose

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

Otc - Keep Out Of Reach Of Children

Keep out of reach of children. If swallowed, get medical help or contacta Poison Control Center right away.

Indications & Usage

Uses - temporarily relieves irritation and burning - helps relieve the local itching and discomfort associated with hemorrhoids - temporarily shrinks hemorrhoidal tissue - aids in protecting irritated anorectal areas Other information - store at 20 degrees - 25 degrees C (68 degrees - 77 degrees F)- for lot number and expiration date, see crimp of tube or see box

Warnings

Warnings For external use only. Ask a doctor before use if you have- heart disease - high blood pressure - thyroid disease - diabetes - trouble urinating due to an enlarged prostate glandAsk a doctor before use if you have- heart disease- high blood pressure- diabetes- thyroid disease- trouble urinating due to an enlarged prostate glandAsk a doctor or pharmacist before use if you are presently taking a prescription drug for high blood pressure or depressionWhen using this product - do not exceed the recommended daily dosage - do not put into rectum by using fingers or any mechanical device or applicatorStop use and ask a doctor if- bleeding occurs- condition worsens or does not improve within 7 daysIf pregnant or breast feeding, ask a health professional before use.Keep out of the 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 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

Inactive Ingredient

Inactive Ingredients aloe barbadensis leaf juice, benzophenone-4, disodium EDTA, hydroxyethylcellulose. methylparaben, polysorbate 80, propylene glycol, propylparaben, purified water, sodium citrate, tocopheryl acetate

* Please review the disclaimer below.