Hemorrhoid Relief Cream

Hemorrhoid Relief Cream
SPL v4
SPL
SPL Set ID 53b2c3b0-d729-44d6-bc64-a9e1c9351877
Route
TOPICAL
Published
Effective Date 2025-11-21
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Lidocaine (50 mg)
Inactive Ingredients
Benzyl Alcohol Carbomer 940 Cholesterol Isopropyl Myristate Lecithin, Soybean Polysorbate 80 Propylene Glycol Water Trolamine .alpha.-tocopherol Acetate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2022-01-28

Description

Active Ingredient Lidocaine 5% W/W

Purpose

Local Anesthetic


Medication Information

Purpose

Local Anesthetic

Description

Active Ingredient Lidocaine 5% W/W

Uses

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

Section 42229-5

*This product is not manufactured or distributed by Ferndale IP, Inc., Owner of the registered trademark RectiCare ®.

Section 50565-1

Keep out of reach of children and pets.If swallowed, get medical help or contact a Poison Control Center.

Warnings

For external use only

When using this product

  • use only as directed.
  • Avoid contact with eyes.
  • do not exceed the recommended dosage unless directed by a doctor. 
  • do not put 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.

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.
Drug Facts

Active Ingredient

Lidocaine 5% W/W

Inactive Ingredient

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

Other information.
  • Store between 15°-30° C (59°-86°F).
Questions Or Comments?

Package Label.principal Display Panel

Hemorrhoid Relief Cream

Lidocaine 5% Anorectal Cream

Helps relieve pain and burning

For temporary relief of itching and discomfort associated with hemorrhoids and other anorectal disorders

Highest lidocaine strength available over-the-counter

Net wt 1oz (30g)


Structured Label Content

Uses

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

Section 42229-5 (42229-5)

*This product is not manufactured or distributed by Ferndale IP, Inc., Owner of the registered trademark RectiCare ®.

Section 50565-1 (50565-1)

Keep out of reach of children and pets.If swallowed, get medical help or contact a Poison Control Center.

Purpose

Local Anesthetic

Warnings

For external use only

When using this product

  • use only as directed.
  • Avoid contact with eyes.
  • do not exceed the recommended dosage unless directed by a doctor. 
  • do not put 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.

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.
Drug Facts

Active Ingredient

Lidocaine 5% W/W

Inactive Ingredient

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

Other information. (Other Information.)
  • Store between 15°-30° C (59°-86°F).
Questions Or Comments? (Questions or Comments?)

Package Label.principal Display Panel (PACKAGE LABEL.PRINCIPAL DISPLAY PANEL)

Hemorrhoid Relief Cream

Lidocaine 5% Anorectal Cream

Helps relieve pain and burning

For temporary relief of itching and discomfort associated with hemorrhoids and other anorectal disorders

Highest lidocaine strength available over-the-counter

Net wt 1oz (30g)


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)