Lidocaine 4% Cream

Lidocaine 4% Cream
SPL v9
SPL
SPL Set ID 70aace2f-47b4-e961-e053-2991aa0a6367
Route
TOPICAL
Published
Effective Date 2017-07-11
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Lidocaine (4 g)
Inactive Ingredients
Phenoxyethanol Mineral Oil Glyceryl Stearate Se Cetyl Alcohol Glycerin Peg-100 Stearate Xanthan Gum Water Stearyl Alcohol Petrolatum Citric Acid Monohydrate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2018-07-10
Description

Lidocaine 4% w/w

Purpose

Topical anesthetic

Medication Information

Purpose

Topical anesthetic

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
Section 51945-4

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 of age: Consult a doctor.
Other Information

Store at USP controlled room temperature 20-25 degC (68-77 deg.F).

Active Ingredient:

Lidocaine 4% w/w

Inactive Ingredients

Cetyl alcohol, citric acid, glycerin, glyceryl stearate SE, mineral oil, PEG-100 stearate, phenoxyethanol, purified water, stearyl alcohol, white petrolatum, xanthan gum

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 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 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
Section 51945-4 (51945-4)

Purpose

Topical anesthetic

Warnings (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 of age: Consult a doctor.
Other Information

Store at USP controlled room temperature 20-25 degC (68-77 deg.F).

Active Ingredient:

Lidocaine 4% w/w

Inactive Ingredients (Inactive ingredients)

Cetyl alcohol, citric acid, glycerin, glyceryl stearate SE, mineral oil, PEG-100 stearate, phenoxyethanol, purified water, stearyl alcohol, white petrolatum, xanthan gum

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 Doctor If (Stop use and ask 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 right away

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:08:14.720117 · Updated: 2026-03-14T23:12:25.780176