Hemorrhoidalcreampro
FDA Label NDC 77338-410

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Astonea Labs Private Limited for the product Hemorrhoidalcreampro (NDC 77338-410). 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, indications & usage, warnings, ask a doctor before use if you have, otc - ask doctor/pharmacist, 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

Other

Drug Facts

Otc - Purpose

Mineral Oil (14% w/w)............................................. Skin Protectant

Petrolatum (74.9% w/w)........................................... Skin Protectant


Phenylephrine HCl (0.25% w/w).................. Vasoconstrictor

Indications & Usage

Uses

  • Helps relieve the anorectal symptoms associated with hemorrhoids (pain, soreness, burning)
  • Temporarily reduces the swelling associated with irritated hemorrhoidal tissue and other anorectal disorders

Warnings

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

Otc - Ask Doctor/Pharmacist

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

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.

Dosage & Administration

Directions

  • Adults: when possible, clean affected area with mild soap or warm water, rinse thoroughly, and then gently dry (patting or blotting) with tissue or soft cloth before use
  • To use applicator, attach it to the tube, lubricate well, then gently insert part way into anus and squeeze tube to deliver medication. Thoroughly cleanse applicator after use with mild soap and warm water and rinse thoroughly
  • Apply externally to the affected area up to 4 times daily, especially at night, when waking up and after each bowel movement
  • Children under 12 years of age: ask a doctor

Storage And Handling

Other information

store at 20-25°C (68-77°F)

Inactive Ingredient

Inactive ingredients

Alpha Tocopherol (Vitamin E), Benzoic Acid, Butylated Hydroxyanisole, Corn Oil, Glycerin, Lanolin, Propylene Glycol, Thymus Vulgaris (Thyme) Flower/Leaf Oil, White Wax

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