SPL v1
SPL
SPL Set ID 4383faaa-49cf-47b7-83a6-c2a94b6ff9b5
Route
TOPICAL
Published
Effective Date 2025-09-05
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Inactive Ingredients
Water Isopropyl Myristate Glycerin Ethoxydiglycol Polyacrylate Crosspolymer-6 Cyclopentasiloxane Polysorbate 60 Phenoxyethanol Ethylhexylglycerin Xanthan Gum

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-09-08

Description

Lidocaine HCL 4%

Purpose

External Analgesic


Medication Information

Purpose

External Analgesic

Description

Lidocaine HCL 4%

Uses

Provides temporary relief from pain and itching caused by sunburns, minor cuts, insect bites, and skin irritations.

Warnings

1. For external use only

2. Avoid contact with the eyes

3. Stop use and consult a doctor if:

  • Condition worsens or symptoms persist for more than 7 days
  • Symptoms clear up and occur again within a few days

Avoid excessive use, especially on raw or blistered skin. Do not

exceed the recommended daily dosage unless advised by a doctor.

Do not useon wounds or damaged skin.

Keep out of reach of children.

If swallowed, seek immediate medical attention or contact a Poison Control Center right away.

Directions

For adults and children aged 2 years and older: Gently apply to the affected area. Up to 3 to 4 times daily as needed.

For children under 2 years: Do not use without consulting a healthcare professional.

Product Label

Active Ingredient

Lidocaine HCL 4%

Other Information

Don’t use if the seal is tampered.

Inactive Ingredients

Agua (Water), Isopropyl myristate , Glycerin, Ethoxydiglycol , Polyacrylate, Crosspolymer-6, Cyclopentasiloxane, Polysorbate, Phenoxyethanol , Ethylhexylglycerin, Xanthan Gum


Structured Label Content

Uses

Provides temporary relief from pain and itching caused by sunburns, minor cuts, insect bites, and skin irritations.

Purpose

External Analgesic

Warnings

1. For external use only

2. Avoid contact with the eyes

3. Stop use and consult a doctor if:

  • Condition worsens or symptoms persist for more than 7 days
  • Symptoms clear up and occur again within a few days

Avoid excessive use, especially on raw or blistered skin. Do not

exceed the recommended daily dosage unless advised by a doctor.

Do not useon wounds or damaged skin.

Keep out of reach of children.

If swallowed, seek immediate medical attention or contact a Poison Control Center right away.

Directions

For adults and children aged 2 years and older: Gently apply to the affected area. Up to 3 to 4 times daily as needed.

For children under 2 years: Do not use without consulting a healthcare professional.

Product Label (Product label)

Active Ingredient

Lidocaine HCL 4%

Other Information (Other information)

Don’t use if the seal is tampered.

Inactive Ingredients

Agua (Water), Isopropyl myristate , Glycerin, Ethoxydiglycol , Polyacrylate, Crosspolymer-6, Cyclopentasiloxane, Polysorbate, Phenoxyethanol , Ethylhexylglycerin, Xanthan Gum


Advanced Ingredient Data


Raw Label Data

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