FDA.reportPublic FDA data

83391-006 Lidocain Pain Relief Patch

Manufacturer
SHENZHEN YUWEN E-COMMERCE CO., LTD.
Effective date
2024-12-08
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 00:41:15

Label at a glance#

ProductAUVON Pain Relief
Active ingredientLIDOCAINE HYDROCHLORIDE
Label structure9 sections

Dosage and administration

Clean and dry the patch application area (no wound or hair), pull to separate the film, peel off one side of the film, apply the exposed patch to the skin, peel off the other side of the film, and press the patch firmly to the skin. Wash hands with cool water after use Cutting first if used on joints Do not repeatedly use or reapply the patch as far as possible Apply to affected area not more than 3-4 times daily

Storage and handling

Avoid storing patches in direct sunlight Protect patches from excessive moisture Please store it at room temperature 20-25 C (68-77F)

Label contents#

Full prescribing information#

AUVON Lidocaine Pain Relief Patch

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Lidocaine HCl 4%

Purposes

OTC - PURPOSE SECTION

Topical Analgestic

Use

INDICATIONS & USAGE SECTION

Temporarily relieves minor pain

Warnings

WARNINGS SECTION

For external use only

Please read all directions and warnings as follows and use only as directed. 

Do not use in large quantities, particularly over raw surfaces or blistered areas

Do not use

OTC - DO NOT USE SECTION

  • Alone if you are under 12 years of age, please consult a doctor
  • If you are allergic to the listed ingredients
  • If the package arrives damaged or opened
  • On cuts, puncture wounds, and damaged, broken, swollen, or irritated skin
  • On eyes and mucous membranes
  • More than one patch on your body at a time or with other topical analgesics at the same time
  • Tightly wrapped or localized heat (e.g. heating pads) in the area of use.

Stop use and ask a doctor

OTC - STOP USE SECTION

  • if symptoms persist for more than 7 days or clear up and occur again within a few days
  • If you experience any signs of deterioration or skin injury, such as redness, irritation, swelling, or blistering

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Keep out of reach of children and pets.If swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • Clean and dry the patch application area (no wound or hair), pull to separate the film, peel off one side of the film, apply the exposed patch to the skin, peel off the other side of the film, and press the patch firmly to the skin.
  • Wash hands with cool water after use
  • Cutting first if used on joints
  • Do not repeatedly use or reapply the patch as far as possible
  • Apply to affected area not more than 3-4 times daily

Storage

STORAGE AND HANDLING SECTION

  • Avoid storing patches in direct sunlight
  • Protect patches from excessive moisture
  • Please store it at room temperature 20-25 C (68-77F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

Dihydroxyaluminum aminoacetate, Glycerin, Kaolin, Methylparaben, Polyacrylic acid, Polysorbate 80, Propylene glycol, Water, Propylparaben, PVP, Sodium polyacrylate, Tartaric acid, Titanium Dioxide, Water

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage description

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
83391-006-012026-01-29C16284748780-149896155-db6b-586f-e063-e6dba90add9083391-006 Lidocain Pain Relief Patch
83391-006-022026-01-29C16284748780-149896155-db6b-586f-e063-e6dba90add9083391-006 Lidocain Pain Relief Patch
83391-006-032026-01-29C16284748780-149896155-db6b-586f-e063-e6dba90add9083391-006 Lidocain Pain Relief Patch
83391-006-042026-01-29C16284748780-149896155-db6b-586f-e063-e6dba90add9083391-006 Lidocain Pain Relief Patch

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
83391-006-01AUVON Pain Relief1 in 1 PATCHPATCH13
83391-006-01AUVON Pain Relief1 in 1 POUCHPATCH13
83391-006-02AUVON Pain Relief1 in 1 PATCHPATCH13
83391-006-02AUVON Pain Relief10 in 1 BOXPATCH103
83391-006-03AUVON Pain Relief18 in 1 BOXPATCH183
83391-006-03AUVON Pain Relief1 in 1 PATCHPATCH13
83391-006-04AUVON Pain Relief30 in 1 BOXPATCH303
83391-006-04AUVON Pain Relief1 in 1 PATCHPATCH13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
83391-006AUVON PAIN RELIEF (LIDOCAINE) PATCH [SHENZHEN YUWEN E-COMMERCE CO., LTD.]38 package rows20241209_8be203e3-9031-4247-bf7a-757a36fd7707.zip

Products#

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

DailyMed product names page 1 of 1 · 17 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
83391-00683391-006-01, 83391-006-02, 83391-006-03, 83391-006-04

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
GLYCERINPDC6A3C0OXIACT
WATER059QF0KO0RIACT
SODIUM POLYACRYLATE (8000 MW)285CYO341LIACT
METHYLPARABENA2I8C7HI9TIACT
PROPYLPARABENZ8IX2SC1OHIACT
DIHYDROXYALUMINUM AMINOACETATEDO250MG0W6IACT
TARTARIC ACIDW4888I119HIACT
POVIDONE, UNSPECIFIEDFZ989GH94EIACT
POLYSORBATE 806OZP39ZG8HIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
POLYACRYLIC ACID (8000 MW)73861X4K5FIACT
KAOLIN24H4NWX5COIACT
LIDOCAINE HYDROCHLORIDEV13007Z41AACTIR

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
28c4688c-abef-25f6-e063-6394a90a83f48be203e3-9031-4247-bf7a-757a36fd77072024-12-08WarningsExact identifier
spl id: 28c4688c-abef-25f6-e063-6394a90a83f4
spl set id: 8be203e3-9031-4247-bf7a-757a36fd7707

Reported adverse events (FAERS/openFDA)#

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