16329ab6-4a33-4c38-85e0-5aad9c75d61d

SPL v2
SPL
SPL Set ID 16329ab6-4a33-4c38-85e0-5aad9c75d61d
Route
topical
Published
Effective Date 2025-07-09
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Inactive Ingredients
water arnica montana flower c13-14 isoparaffin elosulfase alfa dimethyl sulfone emu oil diethylene glycol monoethyl ether ethylhexylglycerin glucosamine sulfate isopropyl palmitate laureth-7 phenoxyethanol polyacrylamide (crosslinked; 2 mole percent bisacrylamide) propylene glycol stearic acid tea tree oil

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2024-07-18

Purpose

External Analgesic

Description

Lidocaine HCL 4%


Medication Information

Warnings
  • For external use only.
  • Avoid contact with eyes

Stop use and ask a doctor if

  • Condition worsens or symptoms persist for more than 7 days
  • Symptoms clear up and occur again within a few days
  • Do not use in large quantities, particularly over raw surfaces or blistered areas. Do not exceed the recommended daily dosage unless directed by a doctor.

Do not use

  • On wounds or damaged skin.
Uses

For the temporary relief of pain and itching associated with sunburns, minor cuts, insect bites, and skin irritations

Purpose

External Analgesic

Other Information

Do not use if seal is broken.

Inactive Ingredients

Aqua (Deionized Water), Arnica Montana Flower Extract,C13-14 Isoparaffin, Chondroitin Sulfate, Dimethyl Sulfone (MSM), Emu Oil,

Ethoxydiglycol, Ethylhexylglycerin, Glucosamine Sulfate, Isopropyl Palmitate, Laureth-7, Phenoxyethanol, Polyacrylamide, Propylene Glycol, Stearic Acid,Tea Tree Oil, Triethanolamine.

Description

Lidocaine HCL 4%

Section 42229-5

Questions? 866-488-0066

Direction

Adults and children 2 years of age and older: Apply to affected area not more than 3 to 4 times daily. Children under 2 years of age: do not use, consult a physician.

Active Ingredient

Lidocaine HCL 4%

Product Label and Box

Keep Out of Reach of Children

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


Structured Label Content

Warnings
  • For external use only.
  • Avoid contact with eyes

Stop use and ask a doctor if

  • Condition worsens or symptoms persist for more than 7 days
  • Symptoms clear up and occur again within a few days
  • Do not use in large quantities, particularly over raw surfaces or blistered areas. Do not exceed the recommended daily dosage unless directed by a doctor.

Do not use

  • On wounds or damaged skin.
Uses

For the temporary relief of pain and itching associated with sunburns, minor cuts, insect bites, and skin irritations

Purpose

External Analgesic

Other Information (Other information)

Do not use if seal is broken.

Inactive Ingredients (Inactive ingredients)

Aqua (Deionized Water), Arnica Montana Flower Extract,C13-14 Isoparaffin, Chondroitin Sulfate, Dimethyl Sulfone (MSM), Emu Oil,

Ethoxydiglycol, Ethylhexylglycerin, Glucosamine Sulfate, Isopropyl Palmitate, Laureth-7, Phenoxyethanol, Polyacrylamide, Propylene Glycol, Stearic Acid,Tea Tree Oil, Triethanolamine.

Section 42229-5 (42229-5)

Questions? 866-488-0066

Direction

Adults and children 2 years of age and older: Apply to affected area not more than 3 to 4 times daily. Children under 2 years of age: do not use, consult a physician.

Active Ingredient

Lidocaine HCL 4%

Product Label and Box (Product label and box)

Keep Out of Reach of Children (Keep out of reach of children)

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


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)