FDA.reportPublic FDA data

Initial Drug Listing - Treatonic LIDOCAINE PAIN RELIEF PATCH

Manufacturer
100 KARMA INC
Effective date
2025-08-08
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 01:12:04

Label at a glance#

ProductTreatonic LIDOCAINE PAIN RELIEF
Active ingredientLIDOCAINE
Label structure9 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Lidocaine 4%

OTC - PURPOSE SECTION

Topical anesthetic

DOSAGE & ADMINISTRATION SECTION

for temporary relief of pain

WARNINGS SECTION

For external use only

OTC - DO NOT USE SECTION

  • 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

OTC - WHEN USING SECTION

  • 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.

OTC - ASK DOCTOR SECTION

  • 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,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

INDICATIONS & USAGE SECTION

  • 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.

OTHER SAFETY INFORMATION

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

INACTIVE INGREDIENT SECTION

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

OTC - QUESTIONS SECTION

Email: service@treatonic.com

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

lidocainelidocaine

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1737778lidocaine 4 % Medicated PatchPSN1
1737778lidocaine 0.04 MG/MG Medicated PatchSCD1
1737778lidocaine 4 % Medicated PatchSY1

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
LIDOCAINE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
070fbed5-7088-434a-a7ce-f2a64d8d40acProduct name220260107
bee66ce1-adb7-9d3b-67d9-582e4c54e80fProduct name520250819
860a93dc-4863-49cc-b284-6bbe8191bc48Product name420250214
eaba870a-6a9d-442e-8643-87b3f558a451Product name120250117
9b4cf230-fd05-41d5-98c6-5db9ecb27b86Product name120230117
7d755fa1-1087-4dcd-98f0-6d4bba479a57Product name320210602
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
aed701d5-9c75-dfaf-7154-cde46179faeaProduct name920200313
fa8b5901-e681-426f-82fe-54f6d81ec698Product name420180619
332d03e4-aa24-4b11-841a-02bf41081920Product name120171221
c08ab52f-2fc8-4409-9d9f-ed8edc0bd070Product name120171221
68ed98f8-24c2-44a0-944a-6d36e82ce25aProduct name120141222
1cd42bc2-a430-c72b-636d-991b235fbf80Product name120140508
49fa150c-f0de-cce7-3d9c-993ed81c5698Product name120140508
4d7ae718-ed00-bae8-2abe-9eaec1eef7ffProduct name120140508
9137811f-f279-8640-5aeb-99fa2145d64dProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
85569-007-01Treatonic LIDOCAINE PAIN RELIEF20 in 1 CARTONPATCH201

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 16 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
85569-00785569-007-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 14 matching rows.

Name, UNII, Kind table
NameUNIIKind
POLYSORBATE 806OZP39ZG8HIACT
WATER059QF0KO0RIACT
LIDOCAINE98PI200987ACTIB
CARBOXYMETHYLCELLULOSE SODIUMK679OBS311IACT
POVIDONE K90RDH86HJV5ZIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
GLYCERINPDC6A3C0OXIACT
EDETATE DISODIUM7FLD91C86KIACT
SODIUM POLYACRYLATE (2500000 MW)05I15JNI2JIACT
CARBOMER0A5MM307FCIACT
TARTARIC ACIDW4888I119HIACT
KAOLIN24H4NWX5COIACT
DMDM HYDANTOINBYR0546TOWIACT
DIHYDROXYALUMINUM AMINOACETATE ANHYDROUS1K713C615KIACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Treatonic LIDOCAINE PAIN RELIEFLIDOCAINE 4%100 KARMA INC3bd66b03-ac82-2d45-e063-6294a90a610a2025-08-08WarningsExact identifier
ndc (package): 85569-007-01
ndc (product): 85569-007
ndc11 (package): 85569000701
spl id: 3bd66b03-ac83-2d45-e063-6294a90a610a
spl set id: 3bd66b03-ac82-2d45-e063-6294a90a610a

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.