SPL v3
SPL
SPL Set ID 293ef514-44c1-43ac-9a81-c30e34ad39e5
Route
TOPICAL
Published
Effective Date 2024-02-26
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Inactive Ingredients
Arnica Montana Flower C13-14 Isoparaffin Dimethyl Sulfone Emu Oil Diethylene Glycol Monoethyl Ether Ethylhexylglycerin Glucosamine Sulfate Glycerin Isopropyl Palmitate Laureth-7 Tea Tree Oil Phenoxyethanol Polyacrylamide (10000 Mw) Propylene Glycol Sodium Chondroitin Sulfate (porcine; 5500 Mw) Stearic Acid Trolamine Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-02-23

Description

Lidocaine HCL 4.0% w/w

Purpose

External Analgesic


Medication Information

Purpose

External Analgesic

Description

Lidocaine HCL 4.0% w/w

Uses

For temporary relief of pain and itching.

Section 50565-1

Warnings
  • For external use only. 
  • Avoid contact with eyes. 
  • Do not use in large quantities, particularly over raw surfaces or blistered areas. 
  • If condition worsens, or if symptoms persist for more than 7 days or clear up and occur again with a few days, discontinue use of this product and consult a doctor. 
  • If product is swallowed get medical help or contact a Poison Control Center right away.
Directions
  • Apply in a circular motion for 30 to 60 seconds over intact skin. 
  • For adults and children two-years and older, apply to affected area not more than 3 to 4 times daily. 
  • Children under 2 years of age consult a physician.
Drug Facts

Questions?

[email protected]

(888) 246-6601

Product Label

Active Ingredient

Lidocaine HCL 4.0% w/w

Other Information

Protect this product from excessive heat and direct sun. 

Inactive Ingredients

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


Structured Label Content

Uses

For temporary relief of pain and itching.

Section 50565-1 (50565-1)

Purpose

External Analgesic

Warnings
  • For external use only. 
  • Avoid contact with eyes. 
  • Do not use in large quantities, particularly over raw surfaces or blistered areas. 
  • If condition worsens, or if symptoms persist for more than 7 days or clear up and occur again with a few days, discontinue use of this product and consult a doctor. 
  • If product is swallowed get medical help or contact a Poison Control Center right away.
Directions
  • Apply in a circular motion for 30 to 60 seconds over intact skin. 
  • For adults and children two-years and older, apply to affected area not more than 3 to 4 times daily. 
  • Children under 2 years of age consult a physician.
Drug Facts

Questions?

[email protected]

(888) 246-6601

Product Label (Product label)

Active Ingredient (Active ingredient)

Lidocaine HCL 4.0% w/w

Other Information (Other information)

Protect this product from excessive heat and direct sun. 

Inactive Ingredients (Inactive ingredients)

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


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)