FDA.reportPublic FDA data

Lidfix Pain Relief Patch Lidocaine

Manufacturer
HETERO HEALTHCARE LIMITED
Effective date
2026-07-27
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
daily-update
Hydrated at
2026-07-29 05:10:11

Label at a glance#

ProductLidfix Pain Relief Patch Lidocaine
Active ingredientLIDOCAINE
Label structure8 sections

Indications and uses

For temporary relief of minor pain

Dosage and administration

 Adults and children 12 years of age and over:  Clean and dry affected area  Remove film from patch and apply to the skin  Use only one patch at a time for up to 12 hours Children under 12 years of age: Consult a doctor

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Lidocaine 4%

Purpose

OTC - PURPOSE SECTION

Topical anesthetic

Uses

INDICATIONS & USAGE SECTION

For temporary relief of minor pain

Warnings

WARNINGS SECTION

(For external use only)

Do not use:

OTC - DO NOT USE SECTION

  •  More than one patch at a time
  •  On wounds or damaged skin
  •  With a heating pad
  •  If you are allergic to any ingredients of this product

When using this product

OTC - WHEN USING SECTION

  •  Use only as directed
  •  Avoid contact with the eyes, mucous membranes or rashes
  •  Do not bandage tightly
  •  Do not use this product immediately after bath or shower

Stop use and ask a doctor if:

OTC - STOP USE SECTION

  •  Localized skin reactions occur, such as rash, itching, redness, irritation, pain, swelling and blistering
  •  Condition worsens
  •  Symptoms persist for more than 7 days
  •  Symptoms clear up and occur again within a few days
  •  Do not use with other topical analgesics
  •  Keep children and pets away from used or disposed patch
  •  Used patches still contain the drug product that can produce serious adverse effects if a child or pet chews or ingests this product

If pregnant or breast-feeding, ask a health professional before use.

OTC - PREGNANCY OR BREAST FEEDING SECTION

Keep out of reach of children.

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 film from patch and apply to the skin
  •  Use only one patch at a time for up to 12 hours

Children under 12 years of age: Consult a doctor

Other information

SPL UNCLASSIFIED SECTION

  • Avoid storing product in direct sunlight, Store at room temperature 20°C-25°C, Do not exceed 30°C.
  •  Protect product from excessive moisture

Inactive ingredients

INACTIVE INGREDIENT SECTION

Styrene Isoprene Styrene Block Copolymer, Alicyclic Saturated Hydrocarbon Resin, Butylated HydroxyToluene, Isopropyl Myristate, Oleic Acid, Propylene Glycol, White Mineral Oil

Questions?

OTC - QUESTIONS SECTION

Call: 1800 103 4696

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

labellabel

Products#

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

DailyMed product names page 1 of 1 · 9 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
87497-00187497-001-00

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
LIDOCAINE98PI200987ACTIB
HYDROGENATED C9 RESIN OIL (SOFTENING POINT 100 C)M5U9WEF78YIACT
STYRENE/ISOPRENE/STYRENE BLOCK COPOLYMERK7S96QM8DVIACT
BUTYLATED HYDROXYTOLUENE1P9D0Z171KIACT
ISOPROPYL MYRISTATE0RE8K4LNJSIACT
OLEIC ACID2UMI9U37CPIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
MINERAL OILT5L8T28FGPIACT

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
Lidfix Pain Relief Patch LidocaineLIDOCAINEHETERO HEALTHCARE LIMITED2149f0e3-1983-4f02-929e-ecd20357f4bb2026-07-27WarningsExact identifier
ndc (package): 87497-001-00
ndc (product): 87497-001
ndc11 (package): 87497000100
spl id: 579c3579-d2e8-cd3a-e063-6294a90ae94a
spl set id: 2149f0e3-1983-4f02-929e-ecd20357f4bb

Reported adverse events (FAERS/openFDA)#

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