SPL v2
SPL
SPL Set ID fbdea732-3f0b-c5a0-e053-6394a90a10a0
Route
TOPICAL
Published
Effective Date 2024-03-22
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Lidocaine (1.2 g)
Inactive Ingredients
Benzyl Alcohol Cholesterol Propylene Glycol Tocopherol Isopropyl Myristate Polysorbate 80 Soybean Lecithin Carbomer Homopolymer Type C

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-04-04
Description

Lidocaine 4% w/w

Purpose

Topical anesthetic

Medication Information

Purpose

Topical anesthetic

Description

Lidocaine 4% w/w

Uses

For the temporary relief of pain, itching and burning associated with hemorrhoids and other anorectal disorders.

Warnings

For external 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 eyternally to the attected area un to 6 times a day.
  • Children under 12 years of age: consult a doctor.
Other Information

Store at USP controlled room temperature 20-25℃ (68-77°F).

Active Ingredients

Lidocaine 4% w/w

Inactive Ingredient

benzyl alcohol, carbomer homopolymer type C 980NF, cholesterol, isopropyl myristate, polysorbate 80, propylene glycol, purified water, soybean lecithin, tocopherol.

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 A Doctor If
  • rectal bleeding occurs
  • condition worsens or does not improve within 7 days
  • allergic reaction occurs
  • symptoms being treated does not subside or if redness, irritation, swelling, pain or other symptoms develop or increase
  • symptoms clear up and return within a few days
Keep Out of Reach of Children.

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

Package Label. Principal Display Panel

Structured Label Content

Uses

For the temporary relief of pain, itching and burning associated with hemorrhoids and other anorectal disorders.

Purpose

Topical anesthetic

Warnings

For external 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 eyternally to the attected area un to 6 times a day.
  • Children under 12 years of age: consult a doctor.
Other Information (Other information)

Store at USP controlled room temperature 20-25℃ (68-77°F).

Active Ingredients

Lidocaine 4% w/w

Inactive Ingredient (Inactive ingredient)

benzyl alcohol, carbomer homopolymer type C 980NF, cholesterol, isopropyl myristate, polysorbate 80, propylene glycol, purified water, soybean lecithin, tocopherol.

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 A Doctor If (Stop use and ask a doctor if)
  • rectal bleeding occurs
  • condition worsens or does not improve within 7 days
  • allergic reaction occurs
  • symptoms being treated does not subside or if redness, irritation, swelling, pain or other symptoms develop or increase
  • symptoms clear up and return within 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.

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

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:08:07.021212 · Updated: 2026-03-14T23:12:15.627416