SPL v3
SPL
SPL Set ID 5f30254d-a28f-443d-8729-5c5dde4a0217
Route
TOPICAL
Published
Effective Date 2025-07-10
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 Active Since 2025-07-10

Description

Lidocaine HCL 5.0% w/w

Purpose

Anorectal (Local Anesthetic)


Medication Information

Purpose

Anorectal (Local Anesthetic)

Description

Lidocaine HCL 5.0% w/w

Uses

For temporary relief of pain and discomfort

Section 50565-1

Warnings

For external use only.

Do not use on broken skin or if allergic to any ingredient.

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

Stop use and ask doctor if condition worsens, or if symptoms persist for more than 7 days or return.

Keep out of reach of children and pets If swallowed get medical help or contact a Poison Control Center right away.

Directions

When Practical, cleanse the affected area with mild soap and warm water and rinse thoroughly. Gently dry by patting or blotting with tissue or a soft cloth before application.

Adults: Apply externally to the affected area.

Keep away from children under 12

Drug Facts

Product Label

Active Ingredient

Lidocaine HCL 5.0% 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 discomfort

Section 50565-1 (50565-1)

Purpose

Anorectal (Local Anesthetic)

Warnings

For external use only.

Do not use on broken skin or if allergic to any ingredient.

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

Stop use and ask doctor if condition worsens, or if symptoms persist for more than 7 days or return.

Keep out of reach of children and pets If swallowed get medical help or contact a Poison Control Center right away.

Directions

When Practical, cleanse the affected area with mild soap and warm water and rinse thoroughly. Gently dry by patting or blotting with tissue or a soft cloth before application.

Adults: Apply externally to the affected area.

Keep away from children under 12

Drug Facts

Product Label (Product label)

Active Ingredient (Active ingredient)

Lidocaine HCL 5.0% 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)