Lidocaine Cream

Lidocaine Cream
SPL v2
SPL
SPL Set ID 01cb19a4-ce22-144d-e063-6294a90a8aa3
Route
TOPICAL
Published
Effective Date 2023-07-31
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Lidocaine (40 mg)
Inactive Ingredients
Benzyl Alcohol Carbomer Homopolymer Type C (allyl Pentaerythritol Crosslinked) Hydrogenated Soybean Lecithin Polysorbate 80 Propylene Glycol Water Trolamine .alpha.-tocopherol Acetate

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-07-31
Description

Drug Facts

Purpose

Topical anesthetic

Storage and Handling

Lidocaine 4% Cream is supplied in: 15g tube NDC: 80425-0351-01 Store at room temperature, 20–25°C (68–77°F) Excursions permitted 15–30°C (59–86°F) [see USP Controlled Room Temperature].

How Supplied

Lidocaine 4% Cream is supplied in: 15g tube NDC: 80425-0351-01 Store at room temperature, 20–25°C (68–77°F) Excursions permitted 15–30°C (59–86°F) [see USP Controlled Room Temperature].

Medication Information

Purpose

Topical anesthetic

Storage and Handling

Lidocaine 4% Cream is supplied in: 15g tube NDC: 80425-0351-01 Store at room temperature, 20–25°C (68–77°F) Excursions permitted 15–30°C (59–86°F) [see USP Controlled Room Temperature].

How Supplied

Lidocaine 4% Cream is supplied in: 15g tube NDC: 80425-0351-01 Store at room temperature, 20–25°C (68–77°F) Excursions permitted 15–30°C (59–86°F) [see USP Controlled Room Temperature].

Description

Drug Facts

Uses

temporarily relieves pain and itching due to

  • minor cuts
  • minor scrapes
  • minor burns
  • sunburn
  • minor skin irritation
  • insect bites
Section 42229-5

Drug Facts

Section 50565-1

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Section 50570-1

Do not use

  • in or near the eyes
  • in large quantities, particularly over raw or blistered areas
Section 51945-4

Directions
  • Adult and children 2 years and older: Apply externally to the affected area up to 3 to 4 times a day.
  • Children under 2 years of age: Consult a doctor.
Questions?

Call 800-936-3088

Active Ingredient

Lidocaine 4% w/w

Other Information
  • May be applied under occlusive dressing.
  • Store at room temperature, 20–25°C (68–77°F) Excursions permitted 15–30°C (59–86°F) [see USP Controlled Room Temperature].
Inactive Ingredients

Benzyl Alcohol, Carbopol 940, Hydrogenated Lecithin, Polysorbate 80, Propylene Glycol, Purified Water, Trolamine and Vitamin E Acetate.

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
How Supplied/storage and Handling

Lidocaine 4% Cream is supplied in:

15g tube NDC: 80425-0351-01

Store at room temperature, 20–25°C (68–77°F) Excursions permitted 15–30°C (59–86°F) [see USP Controlled Room Temperature].

Structured Label Content

Uses

temporarily relieves pain and itching due to

  • minor cuts
  • minor scrapes
  • minor burns
  • sunburn
  • minor skin irritation
  • insect bites
Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Section 50570-1 (50570-1)

Do not use

  • in or near the eyes
  • in large quantities, particularly over raw or blistered areas
Section 51945-4 (51945-4)

Purpose

Topical anesthetic

Directions
  • Adult and children 2 years and older: Apply externally to the affected area up to 3 to 4 times a day.
  • Children under 2 years of age: Consult a doctor.
Questions?

Call 800-936-3088

Active Ingredient

Lidocaine 4% w/w

Other Information
  • May be applied under occlusive dressing.
  • Store at room temperature, 20–25°C (68–77°F) Excursions permitted 15–30°C (59–86°F) [see USP Controlled Room Temperature].
Inactive Ingredients (Inactive ingredients)

Benzyl Alcohol, Carbopol 940, Hydrogenated Lecithin, Polysorbate 80, Propylene Glycol, Purified Water, Trolamine and Vitamin E Acetate.

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
How Supplied/storage and Handling (How Supplied/Storage and Handling)

Lidocaine 4% Cream is supplied in:

15g tube NDC: 80425-0351-01

Store at room temperature, 20–25°C (68–77°F) Excursions permitted 15–30°C (59–86°F) [see USP Controlled Room Temperature].

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:05:11.103012 · Updated: 2026-03-14T23:06:36.654428