1. Home
  2. Labeler Index
  3. Winco Foods, Llc
  4. 67091-278
  5. Label Information: Winco Hemorrhoidal

FDA Label for Winco Hemorrhoidal

View Indications, Usage & Precautions

Table of Contents

    1. OTC - ACTIVE INGREDIENT
    2. OTC - PURPOSE
    3. WARNINGS
    4. OTC - ASK DOCTOR
    5. OTC - WHEN USING
    6. OTC - DO NOT USE
    7. OTC - PREGNANCY OR BREAST FEEDING
    8. OTC - KEEP OUT OF REACH OF CHILDREN
    9. INDICATIONS & USAGE
    10. STORAGE AND HANDLING
    11. INACTIVE INGREDIENT
    12. DOSAGE & ADMINISTRATION
    13. PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Winco Hemorrhoidal Product Label

The following document was submitted to the FDA by the labeler of this product Winco Foods, Llc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

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.