Heb Hemorrhoidal
FDA Label NDC 37808-991

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by H-e-b for the product Heb Hemorrhoidal (NDC 37808-991). 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 other, otc - purpose, uses, warnings, otc - do not use, ask a doctor or pharmacist before use if you are, when using this product, stop use and ask a physician if, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Other

Drug Facts

Otc - Purpose

Active ingredientsPurpose
Mineral Oil 14%Protectant
Petrolatum 74.9%Protectant
Phenylephrine hydrochloride 0.25%Vasoconstrictor

Uses

  • For the temporary relief of anorectal itching and discomfort associated with hemorrhoids.
  • Temporarily reduces swelling associated with irritation in hemorrhoids and other anorectal disorders
  • Temporarily shrinks hemorrhoidal tissue
  • Temporarily forms a protective coating over inflamed tissues to help prevent drying of tissues
  • Temporarily protects the inflamed, irritated anorectal surface to help make bowel movements less painful

Warnings

For external and/or intrarectal use only

Otc - Do Not Use

Do not use this product if you have heart disease, high blood pressure, thyroid disease, diabetes, or difficulty in urination due to enlargement of the prostate gland unless directed by a doctor.

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

Stop Use And Ask A Physician If

  • bleeding occurs
  • condition worsens or does not improve within 7 days
  • introduction of applicator into 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: 800-222-1222.

Directions

  • Adults: when practical, cleanse the affected area by patting or blotting with an appropriate cleansing pad. Gently dry by patting or blotting with a tissue or a soft cloth before application of this product
  • apply externally to the affected area up to 4 times daily
  • intrarectal use: remove cover from applicator, attach applicator to tube, lubricate applicator well and gently insert applicator into the rectum, thoroughly cleanse applicator after each use and replace cover
  • Children under 12 years of age: consult a physician

Other Information

  • Store at 15 to 30°C(59 to 86°F)
  • Tamper Evident: DO NOT USE IF SEAL ON TUBE IS BROKEN OR MISSING.

Inactive Ingredients

Benzoic acid, cera alba (bees wax), glycerin, lanolin, lanolin alcohol, methylparaben, paraffin, propylparaben, purified water, thymus vulgaris (thyme) oil, tocopherol (vitamin E) acetate

Questions Or Comments?

866-323-0107

Principal Display Panel - 56.7 G Tube Carton

Compare to Preperation H® Ointment active ingredients*

H-E-B ®

NDC 37808-991-24

Hemorrhoidal Ointment
Mineral Oil / Petrolatum / Protectant
Phenylephrine Hydrochloride / Vasoconstrictor

Includes
Dispensing
Cap

Hemorrhoid Symptom Relief

  • Helps Relieve Pain & Itching
  • Lubricating Coating Protects Irritated Tissue

    • NET WT 2.0 OZ (56.7 g)

    Principal Display Panel (56.7 g Tube Carton)

    Principal Display Panel (56.7 g Tube Carton)

* Please review the disclaimer below.