SPL v1
SPL
SPL Set ID cafaa830-d894-4590-8928-d579cc791d79
Route
TOPICAL
Published
Effective Date 2025-12-05
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Lidocaine (4 g)
Inactive Ingredients
Arnica Montana Flower C13-14 Isoparaffin Sodium Chondroitin Sulfate (porcine; 5500 Mw) Dimethyl Sulfone Emu Oil Ethylhexylglycerin Glucosamine Sulfate Glycerin Isopropyl Palmitate Laureth-7 Phenoxyethanol Polyacrylamide (1500 Mw) Propylene Glycol Stearic Acid Trolamine Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-10-15

Description

Lidocaine HCL 4.0% w/w

Purpose

Topical Analgesic


Medication Information

Purpose

Topical Analgesic

Description

Lidocaine HCL 4.0% w/w

Uses

For temporary relief of pain and itching.

Warnings

For external use only

Avoid contact with eyes

Do not  use in large quantities, particularly over raw surfaces or blistered areas.

Discontinue use and consult a doctor if

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

Keep out of reach of children

• If the product is swallowed, get medical help or contact a Poison Control Center right away.

Directions

For adults and children 12 years or older: Apply to affected area not more than 3 to 4 times daily.

Children under 12 years of age: consult a physician.

Product Label

Other Information

Protect this product from excessive heat and direct sun.

Active Ingredients

Lidocaine HCL 4.0% w/w

Inactive Ingredients

Arnica Montana Flower Extract, C13-14 Isoparaffin, Chondroitin Sulfate, Dimethyl Sulfone (MSM), Emu Oil, Ethylhexylglycerin, Glucosamine Sulfate, Glycerin, Isopropyl Palmitate, Laureth-7, Phenoxyethanol, Polyacrylamide, Propylene Glycol, Stearic Acid, Triethanolamine, Water


Structured Label Content

Uses

For temporary relief of pain and itching.

Purpose

Topical Analgesic

Warnings

For external use only

Avoid contact with eyes

Do not  use in large quantities, particularly over raw surfaces or blistered areas.

Discontinue use and consult a doctor if

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

Keep out of reach of children

• If the product is swallowed, get medical help or contact a Poison Control Center right away.

Directions

For adults and children 12 years or older: Apply to affected area not more than 3 to 4 times daily.

Children under 12 years of age: consult a physician.

Product Label (Product label)

Other Information (Other information)

Protect this product from excessive heat and direct sun.

Active Ingredients

Lidocaine HCL 4.0% w/w

Inactive Ingredients

Arnica Montana Flower Extract, C13-14 Isoparaffin, Chondroitin Sulfate, Dimethyl Sulfone (MSM), Emu Oil, Ethylhexylglycerin, Glucosamine Sulfate, Glycerin, Isopropyl Palmitate, Laureth-7, Phenoxyethanol, Polyacrylamide, Propylene Glycol, Stearic Acid, Triethanolamine, Water


Advanced Ingredient Data


Raw Label Data

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