Hemorrhoidal Suppository
FDA Label NDC 70795-1021

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Graxcell Pharmaceutical, Llc for the product Hemorrhoidal (NDC 70795-1021). 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 active ingredients (per suppository), purpose, uses, warnings, ask a doctor or pharmacist before use if you are, ask a doctor before use if you have, when using this product, if pregnant or breast-feeding, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredients (Per Suppository)

Cocoa butter 88.44 %

Phenylephrine hydrochloride 0.25 %

Purpose

Protectant

Vasoconstructor

Uses

  • temporarily shrinks hemorrhoidal tissues
  • gives temporary relief to the itching, burning and discomfort associated with hemorrhoids
  • aids in protecting irritated anorectal areas

Warnings

For rectal use only

Ask A Doctor Or Pharmacist Before Use If You Are

presently taking a prescription drug for high blood pressure or depression

Ask A Doctor Before Use If You Have

  • heart disease
  • thyroid disease
  • high blood pressure
  • diabetes
  • difficulty in urination due to enlargement of the prostate gland

When Using This Product

  • do not exceed the recommended daily dosage unless directed by a doctor
  • in case of bleeding or if condition worsens or does not improve within 7 days, consult a doctor promptly

If Pregnant Or Breast-Feeding

ask a health professional before use.

Keep Out Of Reach Of Children

If swallowed, get medical help or contact a Poison Control Center right away.

Directions Adults

  • detach one suppository from the strip. Remove the wrapper before inserting into the rectum.
  • insert one suppository into the rectum up to 4 times daily, especially at night, in the morning or after each bowel movement. Children under 12 years of age: consult doctor

Other Information

Store at room temperature or in a cool place but not over 80° F

Inactive Ingredients

methylparaben, propylparaben, starch

Hemorrhoidal Suppositories Label

GRAXCELL PHARMACEUTICAL, LLC.

NDC 70795-1021-2

*Compare to active ingredients in PREPARATION H

Hemorrhoidal Suppositories

HELPS REDUCE INFLAMMATION AND SWELLING OF HAEMORRHOIDAL TISSUES PROVIDES TEMPORARY RELIEF IN MANY CASES

12 SUPPOSITORIES

Label 1 (2)

Label 1 (2)



GRAXCELL PHARMACEUTICAL, LLC.

NDC 70795-1021-4

*Compare to active ingredients in PREPARATION H

Hemorrhoidal Suppositories

Reduces Internal Swelling I Soothes and Protects

Cocoa Butter 88.44% I Phenylephrine Hydrochloride 0.25%

Prompt Soothing Relief From Painful Burning, Itching and Discomfort Provide Additional Nighttime Relief

24 Suppositories

Label 2 (4)

Label 2 (4)



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