Lidocaine 5% Topical Anorectal Cream

Lidocaine 5% Topical Anorectal Cream
SPL v5
SPL
SPL Set ID a7205326-18dc-2ebb-e053-2995a90a8312
Routes
TOPICAL RECTAL
Published
Effective Date 2020-06-15
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Lidocaine (2 g)
Inactive Ingredients
Polysorbate 80 Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2020-06-15
Description

Lidocaine 5% w/w

Purpose

Local Anesthetic Uses helps relieves pain, itching and burning associated with hemorrhoids and other anorectal disorders

Medication Information

Purpose

Local Anesthetic

Uses

helps relieves pain, itching and burning associated with hemorrhoids and other anorectal disorders

Description

Lidocaine 5% w/w

Usage
  • Adults and children 2 years and older: apply externally to the affected area up to 3-4 times a day.
  • Children under 2 years of age: consult a doctor
Dosage

50 milligrams/gram per application

Warnings

For external use only

Directions
  • 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 soft cloth before applying.
  • Adults and children 12 years and older: apply externally to the affected area up to 6 times a day.
  • Children under 12 years of age: consult a doctor.
Package Label

Other Information
  • Store at USP controlled room temperature 20-25 oC (68-77 oF).
Active Ingredients

Lidocaine 5% w/w

Inactive Ingredients

benzyl alcohol, carbomer 940, cholesterol, hydrogenated lecithin, polysorbate 80, propylene glycol, tocopheryl acetate, trolamine, water.

When Using This Product
  • avoid contact with eyes
  • do not exceed 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 Doctor If
  • rectal bleeding occurs
  • condition worsens or does not improve within 7 days
  • allergic reaction occurs
  • symptom being treated does not subside or if redness, irritation, swelling, pain or other symptoms develop or increase
  • symptoms clear up and return in a few days
Keep Out of Reach of Children

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

Structured Label Content

Usage
  • Adults and children 2 years and older: apply externally to the affected area up to 3-4 times a day.
  • Children under 2 years of age: consult a doctor
Dosage

50 milligrams/gram per application

Purpose

Local Anesthetic

Uses

helps relieves pain, itching and burning associated with hemorrhoids and other anorectal disorders

Warnings

For external use only

Directions
  • 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 soft cloth before applying.
  • Adults and children 12 years and older: apply externally to the affected area up to 6 times a day.
  • Children under 12 years of age: consult a doctor.
Package Label

Other Information (Other information)
  • Store at USP controlled room temperature 20-25 oC (68-77 oF).
Active Ingredients

Lidocaine 5% w/w

Inactive Ingredients (Inactive ingredients)

benzyl alcohol, carbomer 940, cholesterol, hydrogenated lecithin, polysorbate 80, propylene glycol, tocopheryl acetate, trolamine, water.

When Using This Product (When using this product)
  • avoid contact with eyes
  • do not exceed 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 Doctor If (Stop use and ask doctor if)
  • rectal bleeding occurs
  • condition worsens or does not improve within 7 days
  • allergic reaction occurs
  • symptom being treated does not subside or if redness, irritation, swelling, pain or other symptoms develop or increase
  • symptoms clear up and return in a few days
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

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Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:06:07.514206 · Updated: 2026-03-14T23:08:44.584027