Quality Choice Hemorrhoidal
FDA Label NDC 63868-201

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Chain Drug Marketing Association for the product Quality Choice Hemorrhoidal (NDC 63868-201). 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
  • trouble urinating due to an enlarged prostate gland

Otc - Ask Doctor/Pharmacist

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

Otc - When Using

When using this product do not use more than the recommended daily dosage

Otc - Stop Use

Stop use and ask a doctor if

  • bleeding occurs
  • condition gets worse or does not get better within 7 days
  • introduction of the applicator into the rectum causes additional pain

Otc - Pregnancy Or Breast Feeding

If pregnant or breast-feeding, ask a physician 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

  • children under 12 years of age: ask a doctor
  • 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
  • when first opening tube, remove foil seal
  • for intrarectal use: remove protective cover from applicator and attach to tube
  • lubricate applicator well, then gently insert applicator into the rectum
  • thoroughly clean applicator and replace protective cover after each use
  • apply externally to the affected area up to 4 times daily, especially at night, in the morning or after each bowel movement
  • also apply ointment to external area

Storage And Handling

Other information store at 20° to 25°C (68° to 77°F)

Inactive Ingredient

Inactive ingredients glycerin, lanolin, methylparaben, propylparaben, stearyl alcohol, thyme oil, tocopherol acetate, water, white wax

Dosage & Administration

Distributed by:

C.D.M.A., Inc.

43157 W. Nine Mile

Novi, MI 48376-0995

www.qualitychoice.com

Made in Korea

Package Label.Principal Display Panel

Image Description (95128.1)

Image Description (95128.1)

* Please review the disclaimer below.