Lidocaine And Menthol Pain Relieving Patch

Lidocaine And Menthol Pain Relieving Patch
SPL v2
SPL
SPL Set ID d25f25ee-79f8-49e7-9715-0aae305b73e5
Route
TRANSDERMAL
Published
Effective Date 2025-10-24
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Lidocaine (0.04 g) Menthol (0.01 g)
Inactive Ingredients
Dihydroxyaluminum Aminoacetate Edetate Disodium Glycerin Hydroxyacetophenone Kaolin Mineral Oil Polyacrylic Acid (250000 Mw) Polysorbate 80 Povidone K90 Propylene Glycol Sodium Polyacrylate (2500000 Mw) Tartaric Acid Titanium Dioxide Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-10-24

Description

Lidocaine 4%

Purpose

External Anesthetic


Medication Information

Purpose

External Anesthetic

Description

Lidocaine 4%

Use

Temporarily relieves minor pain

Warnings

For external use only

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.

Do Not Use
  • more than one patch on your body at a time 
  • on cut, irritated or swollen skin 
  • on puncture wounds 
  • for more than one week without consulting a doctor 
  • if you are allergic to any active or inactive ingredients 
  • if pouch is damaged or opened
When Using This
  • use only as directed 
  • read and follow all directions and warnings on this carton 
  • do not allow contact with the eyes 
  • do not use at the same time as other topical analgesics 
  • do not bandage tightly or apply local heat (such as heating pads) to the area of use 
  • do not microwave 
  • dispose of used patch in manner that always keeps product away from children and pets. Used patches still contain the drug product that can produce serious adverse effects if a child or pet chews or ingests this patch.
Other Information

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

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 [email protected]

Principal Display Panel

If Pregnant Or Breastfeeding,

ask a health professional before use.

Stop Use and Consult A Doctor If
  • condition worsens 
  • redness is present 
  • irritation develops 
  • symptoms persist for more than 7 days or clear up and occur again within a few days 
  • you experience signs of skin injury, such as pain, swelling, or blistering where the product was applied
Active Ingredients (in Each Patch)

Lidocaine 4%

Keep Out of Reach of Children and Pets.

If swallowed, get medical help or contact a Poison Control Center 1-800-222-1222 right away.


Structured Label Content

Use

Temporarily relieves minor pain

Purpose

External Anesthetic

Warnings

For external use only

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.

Do Not Use (Do not use)
  • more than one patch on your body at a time 
  • on cut, irritated or swollen skin 
  • on puncture wounds 
  • for more than one week without consulting a doctor 
  • if you are allergic to any active or inactive ingredients 
  • if pouch is damaged or opened
When Using This (When using this)
  • use only as directed 
  • read and follow all directions and warnings on this carton 
  • do not allow contact with the eyes 
  • do not use at the same time as other topical analgesics 
  • do not bandage tightly or apply local heat (such as heating pads) to the area of use 
  • do not microwave 
  • dispose of used patch in manner that always keeps product away from children and pets. Used patches still contain the drug product that can produce serious adverse effects if a child or pet chews or ingests this patch.
Other Information (Other information)

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

Inactive Ingredients (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? (Questions or comments?)

Call (307) 410-3813 or email [email protected]

Principal Display Panel

If Pregnant Or Breastfeeding, (If pregnant or breastfeeding,)

ask a health professional before use.

Stop Use and Consult A Doctor If (Stop use and consult a doctor if)
  • condition worsens 
  • redness is present 
  • irritation develops 
  • symptoms persist for more than 7 days or clear up and occur again within a few days 
  • you experience signs of skin injury, such as pain, swelling, or blistering where the product was applied
Active Ingredients (in Each Patch) (Active ingredients (in each patch))

Lidocaine 4%

Keep Out of Reach of Children and Pets. (Keep out of reach of children and pets.)

If swallowed, get medical help or contact a Poison Control Center 1-800-222-1222 right away.


Advanced Ingredient Data


Raw Label Data

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