cafaa830-d894-4590-8928-d579cc791d79

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

Purpose

Topical Analgesic

Description

Lidocaine HCL 4.0% w/w


Medication Information

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.

Uses

For temporary relief of pain and itching.

Purpose

Topical Analgesic

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.

Other Information

Protect this product from excessive heat and direct sun.

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

Description

Lidocaine HCL 4.0% w/w

Product Label

Active Ingredients

Lidocaine HCL 4.0% w/w


Structured Label Content

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.

Uses

For temporary relief of pain and itching.

Purpose

Topical Analgesic

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.

Other Information (Other information)

Protect this product from excessive heat and direct sun.

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

Product Label (Product label)

Active Ingredients

Lidocaine HCL 4.0% w/w


Advanced Ingredient Data


Raw Label Data

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