Orythia Pain Relieving Gel Patch 4% Lidocaine

Manufacturer
Planet (Anhui) Pharmaceutical Co., Ltd.
Effective date
2025-06-27
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 01:06:17

Label at a glance#

ProductOrythia Pain Relieving Lidocaine
Active ingredientLIDOCAINE
Label structure8 sections

Dosage and administration

Adults and children 12 years of age over: • clear 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 us only

Do not use

OTC - DO NOT USE SECTION

• more than 1 patch at a time • with a heating pad

• on wounds or damaged skin • if you are allergic to any 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

• conditions worsen

• sympotms 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 over:

• clear 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-(Ethylhexyl)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

1-888-655-1558 Service@getcareland.com

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LabelLabel

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
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
75568-035-01Orythia Pain Relieving Lidocaine9.1 g in 1 BAGPATCH9.11
75568-035-01Orythia Pain Relieving Lidocaine1 in 1 BOXPATCH11

Products#

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

DailyMed product names page 1 of 1 · 13 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
75568-03575568-035-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

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 Pain Relieving LidocaineLIDOCAINEPlanet (Anhui) Pharmaceutical Co., Ltd.d658d495-dd2c-40b7-9446-6f10040ed55e2025-06-27WarningsExact identifier
ndc (package): 75568-035-01
ndc (product): 75568-035
ndc11 (package): 75568003501
spl id: 3893145a-25e7-9678-e063-6294a90aa827
spl set id: d658d495-dd2c-40b7-9446-6f10040ed55e

Reported adverse events (FAERS/openFDA)#

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