Cvs Hemorrhoidal
FDA Label NDC 59779-752

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Cvs Pharmacy, Inc. for the product Cvs Hemorrhoidal (NDC 59779-752). 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, warnings, otc - ask doctor, otc - ask doctor/pharmacist, otc - when using, otc - pregnancy or breast feeding, otc - keep out of reach of children, 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                                  Purpose

Glycerin 14.4%...................................... Protectant

Phenylephrine HCI 0.25%........................ Vasoconstrictor

Pramoxine HCI 1%..................................Local anesthetic

White Petrolatum 15%.............................Protectant

Otc - Purpose

Uses

  • For temporary relief of pain, soreness and burning
  • Helps relieve the local itching and discomfort associated with hemorrhoids
  • Temporarily shrinks hemorrhoidal tissue
  • Temporarily provides a coating for relief of anorectal discomforts
  • Temporarily protects the inflamed, irritaed anorectal surface to help make bowel movements less painful

    • Other Information

    store at 20-25°C (68-77°F)

Warnings

Warnings

For external use only

Otc - Ask Doctor

Ask a doctor before use if you have

  • heart disease
  • high blood pressure
  • Thyroid disease
  • Diabetes
  • Difficulty in urination due to enlargement of the 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 unless directed by a doctor
  • Do not put into rectum by using fingers or any mechanical device or applicator

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 Poision Control Center right away.

Indications & Usage

Directions

  • Adults: when practical, cleanse the affected area by patting or blottign with an appropriate cleansing wipe. Gently dry by patting or blotting with a tissue or a soft cloth before applying.
  • When first opening the tube, puncture foil seal with top end of cap
  • Apply externally or in the lower portion of the anal canal only
  • Apply to the affected area up to 4 times daily, especially at night, in the morning or after each bowel movement
  • For application in the lower anal canal: remove cover from dispensing cap. Attach dispensing cap to tube, lubricate dispensing cap well, then gently insert dispensing cap partway into the anus.
  • Thoroughly cleanse dispensing cap after each use and replace cover.
  • Children under 12 years of age: ask a doctor

Inactive Ingredient

Inactive ingredients

aloe barbadensis leaf extract, butylated hydroxytoluene, cetosteraly alcohol, cetyl esters, cetyl palmitate, distilled water, glycerol monostearate, isopropyl myristate, lanolin, methylparaben, mineral oil, polysorbate 60, propylene glycol, propylparaben, sodium citrate hydrate, stearic acid, tocopherol acetate

Dosage & Administration

DISTRIBUTED BY:

CVS PHARMACY, INC.

ONE CVS DRIVE

WOONSOCKET, RI 02895 USA

* Please review the disclaimer below.