7 Select Hemorrhoidal Original Strength
FDA Label NDC 10202-526

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by 7-eleven, Inc. for the product 7 Select Hemorrhoidal Original Strength (NDC 10202-526). 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 - stop use, otc - pregnancy or breast feeding, 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

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.