Gnp Hemorrhoidal Cream
FDA Label NDC 46122-776

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Amerisourcebergen Drug Corporation for the product Gnp Hemorrhoidal (NDC 46122-776). 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, purpose, uses, warnings, ask a doctor before use if you have, ask a doctor or pharmacist before use if you are, when using this product, stop use and ask a doctor if, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredients

Glycerin 14.4%

Phenylephrine HCL  0.25%

Pramoxine HCl  1%

White petrolatum  15%

Purpose

Protectant

Vasoconstrictor

Local anasthetic

Protectant

Uses

-for temporary relief of pain, soreness, and burning.

-helps relieve the local itching and discomfort associated with hemorrhoids.

-temporarily shrinks hemorrhoidal tissue.

-temporarily provides a coating for relief of anorectal discomforts.

-temporarily protects the inflamed, irritated anorectal surface to help make bowel movements less painful.

Warnings

For external use only.

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

Ask A Doctor Or Pharmacist Before Use If You Are

presently taking a prescription drug for high blood pressure or depression.

When Using This Product

-do not exceed the recommended daily dosage unless directed by a doctor

-do not put into the rectum by using fingers or any mechanical device or applicator

Stop Use And Ask A Doctor If

-bleeding occurs

-condition worsens or does not improve within 7 days

-an allergic reaction develops

-the symptom being treated does not subside or if redness, irritation, swelling pain, or other symptoms develop or increase

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: 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 cream.
  • when first opening the tube, puncture foil seal with top end of cap
  • apply externally or in the lower portion of the anal canal only
  • apply externally to the affected area up to 4 times daily, especially at night, in the morning or after each bowel movement
  • for application in the lower anal canal: remove cover from dispensing cap. Attach dispensing cap to tube. Lubricate dispensing cap well, then gently insert dispensing cap partway into the anus.
  • thoroughly cleanse dispensing cap after each use and replace cover
  • children under 12 years of age: ask a doctor

Other Information

Storage temperature: not to exceed 30°C (86°F).
Protect from freezing.

Inactive Ingredients

Aloe vera leaf, butylated hydroxytoluene, cetostearyl alcohol, cetyl esters, cetyl palmitate, glyceryl monostearate, isopropyl myristate, lanolin, methylparaben, mineral oil, polysorbate 60, propylene glycol, propylparaben, purified water, sodium citrate, stearic acid, tocopheryl Acetate

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