Cvs Health Hemorrhoidal Cooling
FDA Label NDC 69842-843

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 for the product Cvs Health Hemorrhoidal Cooling (NDC 69842-843). 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, ask a doctor before use if you have, otc - ask doctor/pharmacist, when using this product, stop use and ask a doctor if, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Other

Drug Facts

Distributed by: CVS Pharmacy, Inc.
One CVS Drive, Woonsocket, RI 02895

Otc - Purpose

Active IngredientsPurposes
Phenylephrine HCl 0.25%Vasoconstrictor
Witch hazel 50%Astringent

Uses

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

Warnings

For external use only

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.

When Using This Product

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

Stop Use And Ask A Doctor If

  • bleeding occurs
  • condition worsens or does not improve within 7 days. These may be signs of a serious condition.

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 the 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 tissue. Gently dry by patting or blotting with toilet tissue or soft cloth before applying gel.
  • apply to the affected area up to 4 times daily, especially at night, in the morning or after each bowel movement
  • children under 12 years: ask a doctor

Other Information

  • store at 15 to 30° C (59 to 86°F)
  • close cap tightly after use
  • do not use if seal on tube is punctured or missing

Inactive Ingredients

Aloe barbadensis (aloe) leaf juice, benzophenone-4, disodium EDTA, hydroxyethylcellulose, methylparaben, propylene glycol, propylparaben, purified water, sodium citrate

Questions Or Comments?

866-323-0107 or www.natureplex.com

Principal Display Panel - 26 G Tube Carton

CVSHealth™

Compare to the active ingredients in
Preparation H® Cooling Gel*

NDC 69842-843-01

Hemorrhoidal Cooling Gel
WITH SOOTHING ALOE / FAST COOLING RELIEF

  • Clear, non-greasy formula with a pleasant scent
  • Shrinks swollen hemorrhoidal tissue
  • Prompt cooling relief from painful burning & itching
  • Relieves external discomfort

    • NET WT 0.9 OZ (26 g)

    Principal Display Panel (26 g Tube Carton)

    Principal Display Panel (26 g Tube Carton)

* Please review the disclaimer below.