FDA.reportPublic FDA data

Orythia Maximum Strength 4% Lidocaine Pain Relieving Gel Patches

Manufacturer
Planet (Anhui) Pharmaceutical Co., Ltd.
Effective date
2025-08-18
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 01:10:58

Label at a glance#

ProductOrythia Maximum Strength Lidocaine Pain Relieving
Active ingredientLIDOCAINE
Label structure8 sections

Dosage and administration

Adults and children 12 years of age and over: clean and dry affected area apply 1 patch at a time to affected area, not more than 3 to 4 times daily remove film from patch and apply to the skin Children under 12 years of age:  consult a doctor

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Lidocaine 4.0%

Purpose

OTC - PURPOSE SECTION

Topical anesthetic

Use

INDICATIONS & USAGE SECTION

For temporary relief of pain

WARNINGS

WARNINGS SECTION

For external use only

Do not use

OTC - DO NOT USE SECTION

  • more than 1 patch at a time
  • on wounds or damaged skin
  • with a heating pad
  • if you are allergic to any active ingredients of this product

When using this product

OTC - WHEN USING SECTION

  • use only as directed
  • do not bandage tightly
  • avoid contact with the eyes, mucous membranes or rashes

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • symptoms persist for more than 7 days
  • condition worsen
  • symptoms clear up and occur again within a few days
  • localized skin reactions, such as rash, itching, redness, pain, swelling and blistering develop

If pregnant or breast feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use

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
  • apply 1 patch at a time to affected area, not more than 3 to 4 times daily
  • remove film from patch and apply to the skin

Children under 12 years of age: consult a doctor

OTHER INFORMATION

SPL UNCLASSIFIED SECTION

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

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

Propylene Glycol, PEG-40 Hydrogenated Castor Oil, Vanillyl Butyl Ether, Phenoxyethanol, 3-2-(Ethylhexy) oxyl-1, 2-Propandiol, Glycerol, Azone a-Tocopherol Acetate, Sodium Polyacrylate, Dihydroxyaluminum Aminoacetate, CMC-2Na, Titanium Dioxide, Fumed Silica, Tartaric Acid, Polyacrylic Acid, Urea, Water

QUESTIONS?

OTC - QUESTIONS SECTION

626-839-9001 Service@getcareland.com

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label02Label02

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1737778lidocaine 4 % Medicated PatchPSN2
1737778lidocaine 0.04 MG/MG Medicated PatchSCD2
1737778lidocaine 4 % Medicated PatchSY2

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
75568-037-01Orythia Maximum Strength Lidocaine Pain Relieving9.1 g in 1 BAGPATCH9.12
75568-037-01Orythia Maximum Strength Lidocaine Pain Relieving35 in 1 BOXPATCH352

Products#

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

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
75568-03775568-037-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Name, UNII, Kind table
NameUNIIKind
PROPYLENE GLYCOL6DC9Q167V3IACT
POLYOXYL 40 HYDROGENATED CASTOR OIL7YC686GQ8FIACT
VANILLYL BUTYL ETHERS2ULN37C9RIACT
PHENOXYETHANOLHIE492ZZ3TIACT
GLYCERINPDC6A3C0OXIACT
DIHYDROXYALUMINUM AMINOACETATEDO250MG0W6IACT
TITANIUM DIOXIDE15FIX9V2JPIACT
TARTARIC ACIDW4888I119HIACT
UREA8W8T17847WIACT
WATER059QF0KO0RIACT
LIDOCAINE98PI200987ACTIB

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
Orythia Maximum Strength Lidocaine Pain RelievingLIDOCAINEPlanet (Anhui) Pharmaceutical Co., Ltd.6d6b59f9-f614-4e3c-b07b-32b4591d39f22025-08-18WarningsExact identifier
ndc (package): 75568-037-01
ndc (product): 75568-037
ndc11 (package): 75568003701
spl id: 3cad7c20-cb58-8987-e063-6394a90a3ea7
spl set id: 6d6b59f9-f614-4e3c-b07b-32b4591d39f2

Reported adverse events (FAERS/openFDA)#

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