4% Lidocaine Topical Anesthetic Cream

4% Lidocaine Topical Anesthetic Cream
SPL v3
SPL
SPL Set ID 63327e57-f4c8-4ae6-9d28-cef8697bbdcc
Route
TOPICAL
Published
Effective Date 2025-06-18
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Lidocaine (40 mg)
Inactive Ingredients
Aloe Vera Leaf Benzyl Alcohol Carbomer Homopolymer, Unspecified Type Cetyl Alcohol Cholesterol .alpha.-tocopherol, Dl- Glycerin Hydrogenated Soybean Lecithin Isopropyl Myristate Polysorbate 80 Propylene Glycol Water Sodium Hydroxide Stearic Acid

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2020-04-30
Description

Lidocaine 4% W/W

Purpose

Topical Analgesic

Medication Information

Purpose

Topical Analgesic

Description

Lidocaine 4% W/W

Uses

temporarily relieves pain and itching due to:

  • minor cuts
  • minor scrapes
  • sunburn
  • minor skin irritations
  • minor burns
  • insect bites
Warnings

For external use only.

Directions
  • Adults and children 2 years and older: Apply externally to the affected area up to 3-4 times daily.
  • Children under 2 years:Consult a doctor.
Do Not Use

over large areas of the body.

Drug Facts

Active Ingredient

Lidocaine 4% W/W

Other Information
  • Store at USP controlled room temperature 20° to 25°C (68° to 77°F)
Package Labeling:

Inactive Ingredient

aloe barbadensis leaf extract, benzyl alcohol, carbomer homopolymer, cetyl alcohol, cholesterol, di-alpha tocopherol, glycerin, hydrogenated lecithin, isopropyl myristate, polysorbate 80, propylene glycol, purified water, stearic acid

Questions Or Comments?

1-800-639-3803

When Using This Product
  • do not use in or near the eyes
  • do not use in large quantities, particularly over raw surfaces or blistered areas.
Stop Use and Ask A Doctor If
  • Allergic reaction occurs
  • condition worsens or does not improve within 7 days
  • symptoms clear up and return within a few days
  • redness, irritation, swelling, pain or other symptoms begin or increase
Keep Out of Reach of Children.

If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Structured Label Content

Uses

temporarily relieves pain and itching due to:

  • minor cuts
  • minor scrapes
  • sunburn
  • minor skin irritations
  • minor burns
  • insect bites
Purpose

Topical Analgesic

Warnings

For external use only.

Directions
  • Adults and children 2 years and older: Apply externally to the affected area up to 3-4 times daily.
  • Children under 2 years:Consult a doctor.
Do Not Use (Do not use)

over large areas of the body.

Drug Facts

Active Ingredient (Active ingredient)

Lidocaine 4% W/W

Other Information (Other information)
  • Store at USP controlled room temperature 20° to 25°C (68° to 77°F)
Package Labeling:

Inactive Ingredient (Inactive ingredient)

aloe barbadensis leaf extract, benzyl alcohol, carbomer homopolymer, cetyl alcohol, cholesterol, di-alpha tocopherol, glycerin, hydrogenated lecithin, isopropyl myristate, polysorbate 80, propylene glycol, purified water, stearic acid

Questions Or Comments? (Questions or comments?)

1-800-639-3803

When Using This Product (When using this product)
  • do not use in or near the eyes
  • do not use in large quantities, particularly over raw surfaces or blistered areas.
Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • Allergic reaction occurs
  • condition worsens or does not improve within 7 days
  • symptoms clear up and return within a few days
  • redness, irritation, swelling, pain or other symptoms begin or increase
Keep Out of Reach of Children. (Keep out of reach of children.)

If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:06:24.650109 · Updated: 2026-03-14T23:09:10.710567