FDA Label for Heb Hemorrhoidal

View Indications, Usage & Precautions

Heb Hemorrhoidal Product Label

The following document was submitted to the FDA by the labeler of this product H-e-b. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

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

* Please review the disclaimer below.