293ef514-44c1-43ac-9a81-c30e34ad39e5

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
Purpose

External 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. 
  • 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.
Uses

For temporary relief of pain and itching.

Purpose

External Analgesic

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.
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

Description

Lidocaine HCL 4.0% w/w

Questions?

[email protected]

(888) 246-6601

Section 50565-1

Drug Facts

Product Label

Active Ingredient

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. 
  • 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.
Uses

For temporary relief of pain and itching.

Purpose

External Analgesic

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.
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

Questions?

[email protected]

(888) 246-6601

Section 50565-1 (50565-1)

Drug Facts

Product Label (Product label)

Active Ingredient (Active ingredient)

Lidocaine HCL 4.0% w/w

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:02:49.147891 · Updated: 2026-03-14T23:13:35.542610