Rectaease Hemorrhoid Relief Cream

Rectaease Hemorrhoid Relief Cream
SPL v6
SPL
SPL Set ID c054921a-9f1b-7c75-e053-2995a90a1738
Route
TOPICAL
Published
Effective Date 2026-03-04
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Lidocaine (50 mg)
Inactive Ingredients
Polysorbate 80 Benzyl Alcohol Propylene Glycol Water Alpha-tocopherol Acetate Cholesterol Isopropyl Myristate Light Mineral Oil Aloe Barbadensis Leaf Juice Carbomer Homopolymer, Unspecified Type Sodium Hydroxide

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2021-04-19

Description

Lidocaine 5% w/w

Purpose

Local Anesthetic


Medication Information

Purpose

Local Anesthetic

Description

Lidocaine 5% w/w

Uses

Helps relieve the pain, ithcing and burning associated with hemorrhoids and other anorectal disorders.

Packaging

Directions

Directions:

When practical, clean the affected area with mild soaping warm water and rinse thoroughly.

Gently dry by patting or blotting with a toilet tissue or soft cloth before applying.

Adult and children 12 years of age and older, apply to affected area not more than 6 times a day.

Children under 12 years of age: do not use, ask a doctor

Distributed By

Trifecta Pharmaceuticals USA™

101 NE Third Avenue, Suite 1500

Ft. Lauderdale, FL. 33301, USA

1-888-296-9067

www.trifecta-pharma.com

Warning Section

For External Use Only

Active Ingredient

Lidocaine 5% w/w

Other Information

Store at 20º-25ºC (68º-77ºF)

Inactive Ingredients

Benzyl alcohol, Carbomer 940, Cholesterol, Hydrogenated Lecithin, Isopropyl myristate, Propylene glycol,Trolamine, Vitamin E, polysorbate 80, propylene glycol, purified water

Questions Or Comments

Call 1-888-296-9067

When Using This Product

Avoid contact with the eyes

do not use more than directed unless told to do so by a doctor

do not put directly into the rectum by using fingers or any mechanical device or applicator

Stop Use and Ask A Doctor

Rectal bleeding occurs

Condition worsens

Symptoms persist for more than 7 days or clear up and return within a few days

Symptoms being treated does not subside or if redness, irritation, swelling, pain or other symptoms develop or increase.

If Pregnant Or Breast Feeding

Ask doctor before use

Keep Out of Reach of Children

If swallowed get medical help or contact a Poison Control Center right away


Structured Label Content

Uses

Helps relieve the pain, ithcing and burning associated with hemorrhoids and other anorectal disorders.

Purpose

Local Anesthetic

Packaging

Directions

Directions:

When practical, clean the affected area with mild soaping warm water and rinse thoroughly.

Gently dry by patting or blotting with a toilet tissue or soft cloth before applying.

Adult and children 12 years of age and older, apply to affected area not more than 6 times a day.

Children under 12 years of age: do not use, ask a doctor

Distributed By

Trifecta Pharmaceuticals USA™

101 NE Third Avenue, Suite 1500

Ft. Lauderdale, FL. 33301, USA

1-888-296-9067

www.trifecta-pharma.com

Warning Section

For External Use Only

Active Ingredient

Lidocaine 5% w/w

Other Information

Store at 20º-25ºC (68º-77ºF)

Inactive Ingredients

Benzyl alcohol, Carbomer 940, Cholesterol, Hydrogenated Lecithin, Isopropyl myristate, Propylene glycol,Trolamine, Vitamin E, polysorbate 80, propylene glycol, purified water

Questions Or Comments (Questions or Comments)

Call 1-888-296-9067

When Using This Product (When using this product)

Avoid contact with the eyes

do not use more than directed unless told to do so by a doctor

do not put directly into the rectum by using fingers or any mechanical device or applicator

Stop Use and Ask A Doctor (Stop use and ask a doctor)

Rectal bleeding occurs

Condition worsens

Symptoms persist for more than 7 days or clear up and return within a few days

Symptoms being treated does not subside or if redness, irritation, swelling, pain or other symptoms develop or increase.

If Pregnant Or Breast Feeding (If Pregnant or Breast Feeding)

Ask doctor before use

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


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)