Hemorrhoid Relief Cream
FDA Label NDC 73492-712

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Alaina Healthcare Private Limited for the product Hemorrhoid Relief Cream (NDC 73492-712). 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 drug facts active ingredient, purpose, uses, warnings  for external use only, otc - keep out of reach of children, directions, other information., inactive ingredient, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Drug Facts Active Ingredient

Lidocaine 5% W/W

Purpose

Local Anesthetic

Uses

helps relieve the pain, itching, and burning, associated with hemorrhoids and anorectal disorders.

Warnings  For External Use Only

    When using this product 

  • use only as directed.
  • Avoid contact with eyes. 
  • do not exceed recommended dosage unless directed by a doctor. 
  • do not out this product into the rectum by using fingers or any mechanical device or applicator.

    Stop use and ask a doctor if 
  • rectal bleeding occurs. 
  • condition worsens or does not improve within 7 days. 
  • symptoms clear up and occur again within a few days. 
  • an allergic reaction develops to ingredients in this product. 
  • 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.

Otc - Keep Out Of Reach Of Children

keep out of reach of children and pets. If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Directions

Adult and children 12 years and over:

  • When practical, cleanse the affected area with mild soap and warm water and rinse thoroughly, gently dry by patting or blotting with toilet tissue or a soft cloth before application of this product.
  • apply externally to the affected area up to 6 times a day children under 12 years of age: consult a doctor.

Other Information.

  • Store between 15°-30° C (59°-30° F).

Inactive Ingredient

Benzyl Alcohol, Carbomer 940, Cholesterol, Isopropyl Myristate, Lecithin (Soya), Polysorbate 80, Propylene Glycol, Purified Water, Triethanolamine, Vitamin-E Acetate.

Questions Or Comments? 1-888-287-1915

Package Label.Principal Display Panel

Hemorrhoid Relief Cream-Tube - NDC 73492-712-28 - Label.

Hemorrhoid Relief Cream-tube (NDC 73492-712-28)

Hemorrhoid Relief Cream-tube (NDC 73492-712-28)

Hemorrhoid Relief Cream-Tube - NDC 73492-712-28 - Carton.

Hemorrhoid Relief Cream-tube (NDC 73492-712-28)

Hemorrhoid Relief Cream-tube (NDC 73492-712-28)

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