FDA.reportPublic FDA data

LidoMedix

Manufacturer
Absolute Therapeutics, LLC
Effective date
2026-06-09
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
daily-update
Hydrated at
2026-07-15 00:32:55

Label at a glance#

ProductLidoMedix
Active ingredientCAMPHOR (NATURAL), MENTHOL, LIDOCAINE
Label structure12 sections

Dosage and administration

Adults and children 12 years of age and over: Clean and dry affected area. Remove patch from plastic liner and place on affected area. Use 1 patch for up to 12 hours. Place used patch on the liner when not in use. Reuse the patch up to 2 times. Wash hands after applying or removing patch. Throw away the patch by folding sticky ends together. Children under 12 years of age: consult a doctor.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Lidocaine 4%

Purpose

OTC - PURPOSE SECTION

External Anesthetic

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Menthol 0.5%

Purpose

OTC - PURPOSE SECTION

External Analgesic

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Camphor 0.2%

Purpose

OTC - PURPOSE SECTION

External Analgesic

Use

INDICATIONS & USAGE SECTION

For the temporary relief of minor aches and pains of muscles and joints

Warnings

WARNINGS SECTION

For external use only

Do not use

OTC - DO NOT USE SECTION

  • More than one patch on your body at a time
  • On cut, irritated or swollen skin
  • On puncture wounds
  • Over raw surfaces or blistered areas
  • 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 product

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 as other topical analgesics
  • Do not bandage tightly or apply local heat to the area of use
  • 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.

Stop use and consult a doctor if

OTC - STOP USE 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
  • You experience signs of skin injury, such as pain, swelling or blistering where the product was applied

If pregnant or breastfeeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

consult a healthcare professional before use.

Keep out of reach of children and pets.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • Adults and children 12 years of age and over: Clean and dry affected area. Remove patch from plastic liner and place on affected area. Use 1 patch for up to 12 hours. Place used patch on the liner when not in use. Reuse the patch up to 2 times. Wash hands after applying or removing patch. Throw away the patch by folding sticky ends together.
  • Children under 12 years of age: consult a doctor.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Aqua, Glycerol, Magnesium, Polyacrylate, Polysorbate 80

Package Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

pouchpouch

boxbox

Products#

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

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
87599-15087599-150-02, 87599-150-30

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

Name, UNII, Kind table
NameUNIIKind
CAMPHOR (NATURAL)N20HL7Q941ACTIB
SODIUM POLYACRYLATE (2500000 MW)05I15JNI2JIACT
MENTHOLL7T10EIP3AACTIB
GLYCERINPDC6A3C0OXIACT
LIDOCAINE98PI200987ACTIB
WATER059QF0KO0RIACT
MAGNESIUMI38ZP9992AIACT
POLYSORBATE 806OZP39ZG8HIACT

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
LidoMedixLIDOCAINE, MENTHOL, CAMPHORAbsolute Therapeutics, LLC53d504ef-eea3-6a47-e063-6394a90a1f652026-06-09WarningsExact identifier
ndc (package): 87599-150-02
ndc (package): 87599-150-30
ndc (product): 87599-150
ndc11 (package): 87599015030
ndc11 (package): 87599015002
spl id: 53d504ef-eea4-6a47-e063-6394a90a1f65
spl set id: 53d504ef-eea3-6a47-e063-6394a90a1f65

Reported adverse events (FAERS/openFDA)#

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