Lidocaine and Menthol Pain Relieving Patch

Manufacturer
Marcella Health
Effective date
2025-11-03
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 01:42:26

Key Label Information

Active Ingredients And Purpose

Active ingredients (in each patch)

Lidocaine 4%

Purpose

External Anesthetic

Active ingredients (in each patch)

Menthol 1%

Purpose

External Analgesic

Uses

Use

Temporarily relieves minor pain

Warnings

Warnings

For external use only

Directions And Dosage

Directions

Adults and children 12 years of age and over: clean and dry affected area, free of lotions, ointments, and creams. Carefully remove backing from patch starting at a corner. Apply sticky side of patch to affected area. Do not use more than one patch in a 12-hour period. Maximum 2 patches per day. Discard patch after single use. Children under 12 years of age: consult a physician.

Other Label Information

Inactive ingredients

dihydroxyaluminum aminoacetate, edetate disodium, glycerin, hydroxyacetophenone, kaolin, mineral oil, polyacrylic acid, polysorbate 80, povidone K90, propylene glycol, sodium polyacrylate, tartaric acid, titanium dioxide, water

Questions or comments?

Call (307) 410-3813 or email info@marcellahealth.com

Principal Display Panel

Products

NDC Codes

Ingredients

Complete SPL Sections

Active ingredients (in each patch)

OTC - ACTIVE INGREDIENT SECTION

Lidocaine 4%

Purpose

OTC - PURPOSE SECTION

External Anesthetic

Active ingredients (in each patch)

OTC - ACTIVE INGREDIENT SECTION

Menthol 1%

Purpose

OTC - PURPOSE SECTION

External Analgesic

Use

INDICATIONS & USAGE SECTION

Temporarily relieves minor pain

Warnings

WARNINGS SECTION

For external use only

Directions

DOSAGE & ADMINISTRATION SECTION

Adults and children 12 years of age and over: clean and dry affected area, free of lotions, ointments, and creams. Carefully remove backing from patch starting at a corner. Apply sticky side of patch to affected area. Do not use more than one patch in a 12-hour period. Maximum 2 patches per day. Discard patch after single use. Children under 12 years of age: consult a physician.

Other information

SPL UNCLASSIFIED SECTION

Store in a clean, dry place outside of direct sunlight. Protect from excessive moisture.

Inactive ingredients

INACTIVE INGREDIENT SECTION

dihydroxyaluminum aminoacetate, edetate disodium, glycerin, hydroxyacetophenone, kaolin, mineral oil, polyacrylic acid, polysorbate 80, povidone K90, propylene glycol, sodium polyacrylate, tartaric acid, titanium dioxide, water

Questions or comments?

OTC - QUESTIONS SECTION

Call (307) 410-3813 or email info@marcellahealth.com

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Source Document

Official SPL XML cached by FDA.report ยท DailyMed PDF

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XML SHA-256
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XML bytes
25368

Legacy File Index

FolderFileDate
otc42b74ab1-9fcb-d21f-e063-6294a90a21eb.xml2025-11-07
otcLidocaine Menthol Patch Carton Back 091025.jpg2025-11-07
otcLidocaine Menthol Patch Carton Front 091025.jpg2025-11-07