SPL v4
SPL
SPL Set ID fed833f5-4f76-46e8-8ae1-655a9e576f70
Route
TOPICAL
Published
Effective Date 2024-12-09
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 Isopropyl Palmitate Laureth-7 Tea Tree Oil Phenoxyethanol Polyacrylamide (10000 Mw) Propylene Glycol Chondroitin Sulfate (porcine; 5500 Mw) Stearic Acid Trolamine Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Completed Since 2024-11-29 Until 2024-12-09

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

Do not useon wounds or damaged skin, in large quantities, or if you are allergic to any ingredients of this product.

When using this productuse only as directed. Avoid contact with the eyes, rashes, or mucous membranes.

Stop use and ask doctor ifcondition 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 and pets

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

Directions

Adults and children 12 years of age and over:Clean and dry affected area, apply to affected area not more than 3 to 4 times daily.

Children 12 years of age or younger: ask a doctor.

Drug Facts

Product Label

Active Ingredient

Lidocaine HCL 4.0% w/w

Other Information

Protect this product from excessive heat and direct sun.

Inactive Ingredients

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


Structured Label Content

Uses

For temporary relief of pain and itching 

Section 50565-1 (50565-1)

Purpose

External Analgesic

Warnings

For External Use Only

Do not useon wounds or damaged skin, in large quantities, or if you are allergic to any ingredients of this product.

When using this productuse only as directed. Avoid contact with the eyes, rashes, or mucous membranes.

Stop use and ask doctor ifcondition 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 and pets

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

Directions

Adults and children 12 years of age and over:Clean and dry affected area, apply to affected area not more than 3 to 4 times daily.

Children 12 years of age or younger: ask a doctor.

Drug Facts

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)

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


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)