Winco Hemorrhoidal Cream
FDA Label NDC 67091-278

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Winco Foods, Llc for the product Winco Hemorrhoidal (NDC 67091-278). 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 - when using, otc - do not use, 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 (in each gram)                                                                       Purpose

Mineral oil 14%  ---------------------------------------------------------------------      Protectant

Petrolatum 74.9%-------------------------------------------------------------------       Protectant

Phenylephrine hydrochloride 0.25% -----------------------------------------------       Vasoconstrictor

Otc - Purpose

Uses

  • Helps relieve the local itching and discomfort associated with hemorrhoids
  • Temporarily shrinks hemorrhoidal tissue and relieves burning
  • Temporarily provides a coating for relief or anorectal discomforts
  • temporarily portects the inflamed, irritated anorectal surface to help make bowel movements less painful

Warnings

For External use only and/or intrarectal use only

Children under 12 years of age:ask a doctor

Otc - Ask Doctor

Ask a doctor before use if you have

heart disease, high blood pressure, thyroid disease, diabetes, difficulty urinating due to enlargement of the prostate gland

Ask a doctor or pharmacist before use if you are presently taking a prescription drug for high blood pressure or depresion

Otc - When Using

When using this product do not exceed the recommended daily dosage unless directly by a doctor

Otc - Do Not Use

Stop use and ask a doctor if

bleeding occurs, condition worsens or does not improve within 7 days, introduction of applicator into the rectum causes additional pain

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 childern.

If swallowed, get medical help or contact a Poison Control Center right away.

Indications & Usage

Adults: when practical, cleanse the affected area by patting or blotting with an appropriate cleansing wipe

gently dry by patting or blotting with a tissue or a soft cloth before applying ointment

when first opening tube, remove foil seal

apply to the affected area up to 4 times daily, especially at night, in the morning or after each bowel movement

Intrarectal use: remove cover from applicator, attach applicator to tube, lubricate applicator well and gently insert applicator into the rectum

thoroughly cleanse applicator after each use and replace cover

also apply ointment to external area

regular use provides continual therapy for relief of symptoms

Storage And Handling

Other information:

  • store between 20° yp 25°C (68° to 77°F)
  • Lot No. & Exp. Date:see box or see crimp of tube

Inactive Ingredient

Inactive ingredients

ethanol, glycerin, lanolin, methylparaben, polyborbate 80, propylparaben, stearyl alcohol, thyme oil, tocopherol acetate, water, white wax

Dosage & Administration

DISTRIBUTED BY:

WINCO FOODS, LLC,

BOISE, ID 83704

MADE IN KOREA

* Please review the disclaimer below.