Premier Value Hemorrhoidal
FDA Label NDC 68016-840

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 Consortium, Llc for the product Premier Value Hemorrhoidal (NDC 68016-840). 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 - stop 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                                                                 Purpose

Mineral Oil 14%................................................................ Protectant

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

Phenylephrine HCI 0.25%................................................... Vasconstrictor

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 surface to help make bowel movements less painful

Warnings

Warnings

For external and/or intrarectal use only

Otc - Ask Doctor

Ask a doctor or 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 exceed the recommended daily dosage unless directed by a doctor

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 soft cloth before applying
  • when first opening tube, remove foil seal
  • for intrarectal use: remove protective cover from applicator and attach to tube
  • lubricate 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 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:

CHAIN DRUG CONSORTIUM

3301 NW BOCA RATON BLVD

SUITE 101

BOCA RATON, FL 33431

MADE IN KOREA

Package Label.Principal Display Panel

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