Initial Drug Listing - Treatonic Lidocaine Pain Relief Patch

Initial Drug Listing - Treatonic Lidocaine Pain Relief Patch
SPL v1
SPL
SPL Set ID 3bd66b03-ac82-2d45-e063-6294a90a610a
Route
TOPICAL
Published
Effective Date 2025-08-31
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Lidocaine (4 mg)
Inactive Ingredients
Polysorbate 80 Water Carboxymethylcellulose Sodium Povidone K90 Propylene Glycol Glycerin Edetate Disodium Sodium Polyacrylate (2500000 Mw) Carbomer Tartaric Acid Kaolin Dmdm Hydantoin Dihydroxyaluminum Aminoacetate Anhydrous

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-08-31

Description

Lidocaine 4%


Medication Information

Warnings and Precautions

For external use only

Indications and Usage
  • Clean and dry affected area, Carefully remove backing from patch starting at a corner. Apply sticky side of patch to affected area. Use one patch for up to 8 hours. Discard patch after single use.
  • Children under 12 years of age: consult a physician.
Dosage and Administration

for temporary relief of pain

Description

Lidocaine 4%

Section 50565-1

In case of accidental ingestion, seek medical advice immediately or contact a Poison Control Center right away.

Section 50567-7
  • 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 with other topical analgesics
  • do not bandage tightly or apply local heat (such asheating pads) to the area ofuse,
  • do not microwave
  • dispose of used patch in amanner that always keeps product away from children and pets
  • used patches still contain drug product that can produce serious adverse effects if a child or pet chews or ingests this patch.
Section 50569-3
  • condition worsens
  • redness is present
  • irritation develops
  • symptoms persist for more than 7 days or clear up and occur again within a few days
  • develop signs of skin injury, including pain, swelling, or blistering where the product was applied,
Section 50570-1
  • more than one patch on your body at a time
  • on cut, irritated or swollenskin
  • 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
Section 51727-6

Sodium Polyacrylate, Carboxymethylcellulose Sodium, Edetate Disodium, Kaolin,Dihydroxyaluminum Aminoacetate Anhydrous, DMDM Hydantoin, Carbomer, Glycerin,Propylene Glycol, Povidone K90, Polysorbate 80, Water, Tartaric Acid.

Section 51945-4

Section 53413-1
Section 53414-9

ask a health professional before use

Section 55105-1

Topical anesthetic

Section 55106-9

Lidocaine 4%

Section 60561-8

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


Structured Label Content

Indications and Usage (34067-9)
  • Clean and dry affected area, Carefully remove backing from patch starting at a corner. Apply sticky side of patch to affected area. Use one patch for up to 8 hours. Discard patch after single use.
  • Children under 12 years of age: consult a physician.
Dosage and Administration (34068-7)

for temporary relief of pain

Warnings and Precautions (34071-1)

For external use only

Section 50565-1 (50565-1)

In case of accidental ingestion, seek medical advice immediately or contact a Poison Control Center right away.

Section 50567-7 (50567-7)
  • 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 with other topical analgesics
  • do not bandage tightly or apply local heat (such asheating pads) to the area ofuse,
  • do not microwave
  • dispose of used patch in amanner that always keeps product away from children and pets
  • used patches still contain drug product that can produce serious adverse effects if a child or pet chews or ingests this patch.
Section 50569-3 (50569-3)
  • condition worsens
  • redness is present
  • irritation develops
  • symptoms persist for more than 7 days or clear up and occur again within a few days
  • develop signs of skin injury, including pain, swelling, or blistering where the product was applied,
Section 50570-1 (50570-1)
  • more than one patch on your body at a time
  • on cut, irritated or swollenskin
  • 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
Section 51727-6 (51727-6)

Sodium Polyacrylate, Carboxymethylcellulose Sodium, Edetate Disodium, Kaolin,Dihydroxyaluminum Aminoacetate Anhydrous, DMDM Hydantoin, Carbomer, Glycerin,Propylene Glycol, Povidone K90, Polysorbate 80, Water, Tartaric Acid.

Section 51945-4 (51945-4)

Section 53413-1 (53413-1)
Section 53414-9 (53414-9)

ask a health professional before use

Section 55105-1 (55105-1)

Topical anesthetic

Section 55106-9 (55106-9)

Lidocaine 4%

Section 60561-8 (60561-8)

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


Advanced Ingredient Data


Raw Label Data

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