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  5. Label Information: 7 Select Hemorrhoidal Original Strength

FDA Label for 7 Select Hemorrhoidal Original Strength

View Indications, Usage & Precautions

Table of Contents

    1. OTC - ACTIVE INGREDIENT
    2. OTC - PURPOSE
    3. WARNINGS
    4. OTC - ASK DOCTOR
    5. OTC - ASK DOCTOR/PHARMACIST
    6. OTC - WHEN USING
    7. OTC - STOP USE
    8. OTC - PREGNANCY OR BREAST FEEDING
    9. OTC - KEEP OUT OF REACH OF CHILDREN
    10. INDICATIONS & USAGE
    11. STORAGE AND HANDLING
    12. INACTIVE INGREDIENT
    13. DOSAGE & ADMINISTRATION
    14. PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

7 Select Hemorrhoidal Original Strength Product Label

The following document was submitted to the FDA by the labeler of this product 7-eleven, Inc.. 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                                                   Purpose

Mineral oil 14%......................................................Protectant

Petrolatum 74.9%..................................................Protectant

Phenylephrine HCl 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 of anorectal discomforts
  • temporarily protects the inflamed, irritated anorectal surface to help make bowel movements less painful

Warnings



Warnings

For external and/or intrarectal 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.


Otc - Stop 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 children. If swallowed, get medical help or contact a Poison Control Center right away.


Indications & Usage



Directions

  • 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 the 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

Storage And Handling



Other information

  • store at 20-25°C (68-77°F)
  • lot no. & exp. date: see box or see crimp of tube

Inactive Ingredient



Inactive ingredients 

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


Dosage & Administration



DISTRIBUTED BY 7-ELEVEN, INC.

Irving, TX 75063

WWW.7-ELEVEN.COM

Made in Korea


* Please review the disclaimer below.