FDA Label for Heb Maximum Strength Pain Relief Hemorrhoidal

View Indications, Usage & Precautions

Heb Maximum Strength Pain Relief Hemorrhoidal Product Label

The following document was submitted to the FDA by the labeler of this product Heb. 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 ingredientsPurposes
Glycerin 14.4%Protectant
Petrolatum 15%Protectant
Phenylephrine hydrochloride 0.25%Vasoconstrictor
Pramoxine hydrochloride 1%Local Anesthetic

Uses



  • temporarily relieves pain, soreness, and burning
  • helps relieve 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 urinating due to enlargement of the prostate gland

Otc - Ask Doctor/Pharmacist



Ask a doctor or pharmacist before use if you are 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 rectum by using fingers or any mechanical device or applicator

Stop Use And Ask A Physician If



  • bleeding occurs
  • the condition worsens or does not improve within 7 days
  • an allergic reaction develops
  • the symptom being treated does not subside or redness, irritation, swelling, pain, or other symptoms develops, persists, or increase

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 affected area by patting or blotting with appropriate cleansing wipe. Gently dry by patting or blotting with tissue or soft cloth before applying cream.
  • when first opening tube, remove foil seal
  • apply externally or in lower portion of anal canal only
  • apply externally to affected area up to 4 times daily, especially at night, in the morning, or after each bowel movement
  • for application in lower anal canal; remove cover from dispensing cap. Attach dispensing cap to tube. Lubriate dispensing cap well, then gently insert dispensing cap partway into anus
  • thoroughly cleanse dispensing cap after each use, and replace cover
  • Children under 12 years: ask a doctor

Other Information



  • store at 15 to 30°C (59 to 86°F).
  • close cap tightly after use
  • Tamper Evident: DO NOT USE IF SEAL ON TUBE IS PUNCTURED OR MISSING.

Inactive Ingredients



aloe barbadensis leaf juice, BHA, cetyl alcohol, citric acid, disodium EDTA, glyceryl stearate, laureth-23, methylparaben, mineral oil, panthenol, propyl gallate, propylene glycol, propylparaben, purified water, sodium benzoate, sodium carboxymethylcellulose, steareth-2, steareth-20, stearyl alcohol, tocopherol (vitamin E) acetate, xanthan gum


Questions Or Comments?



866-323-0107


Principal Display Panel - 56.7 G Tube Carton



Compare to Preperation H® Cream active ingredients*

NDC 37808-992-24

H-E-B®

Maximum Strength Pain Relief
Hemorrhoidal Cream
Phenylephrine Hydrochloride / Vasoconstrictor • Pramoxine Hydrochloride / Local Anesthetic

Hemorrhoid Symptom Relief

With Soothing Aloe
• Rapid, Soothing Pain Relief from Painful Burning, Itching and Discomfort
• Shrinks Swollen Hemorrhoidal Tissue • Protects Irritated Tissue
• Relieves External Discomfort

Includes
Dispensing
Cap

NET WT 2.0 OZ (56.7 g)


* Please review the disclaimer below.