FDA.reportPublic FDA data

AUVON Pain Relief Roll-on

Manufacturer
SHENZHEN YUWEN E-COMMERCE CO., LTD.
Effective date
2024-12-08
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:41:15

Label at a glance#

ProductAUVON Pain Relief Roll-on
Active ingredientLIDOCAINE HYDROCHLORIDE
Label structure9 sections

Dosage and administration

Apply a thin layer to the affected area every 6 to 8 hours Use no more than three times in a 24-hour period.

Storage and handling

Store it in a dry place at room temperature between 20-25 C (68-77F)

Label contents#

Full prescribing information#

AUVON Lidocaine Pain Relief Roll-on

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

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

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.
  • If you are pregnent or breast feeding
  • At the same time as other topical analgesics
  • On eyes, mucous membranes, cuts, wounds, damaged, broken, swollen, or irritated skin

Discontinue use and consult 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

Keep outof reach of children and pets.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If ingested, get medical help right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • Apply a thin layer to the affected area every 6 to 8 hours
  • Use no more than three times in a 24-hour period.

Storage

STORAGE AND HANDLING SECTION

Store it in a dry place at room temperature between 20-25 C (68-77F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

Acrylates/c10-30 Alkyl Acrylate Crosspolymer, Aloe Barbadensis Leaf Juice, AminomethyI Propanol, Cetearyl Alcohol, Ceteth-10 Phosphate,Cyclopentasiloxane, DicetyI Phosphate, Dimethicone,Dimethicone/Vinyl Dimethicone Crosspolymer, Disodium EDTA, Ethylhexylglycerin, Glyceryl Stearate, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Isohexadecane, Lavandula Angustifolia (Lavender) Oil, Phenoxyethanol, SD Alcohol, Steareth-21, Water

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage description

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1987647lidocaine hydrochloride 4 % Topical SolutionPSN2
1987647lidocaine hydrochloride 40 MG/ML Topical SolutionSCD2
1987647lidocaine hydrochloride 4 % Topical SolutionSY2

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
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
83391-004-01AUVON Pain Relief Roll-on74 mL in 1 BOTTLESOLUTION742
83391-004-02AUVON Pain Relief Roll-on74 mL in 1 BOTTLESOLUTION742
83391-004-02AUVON Pain Relief Roll-on1 in 1 PACKAGESOLUTION12
83391-004-03AUVON Pain Relief Roll-on2 in 1 PACKAGESOLUTION22
83391-004-03AUVON Pain Relief Roll-on74 mL in 1 BOTTLESOLUTION742

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
83391-004AUVON PAIN RELIEF ROLL-ON (LIDOCAINE) SOLUTION [SHENZHEN YUWEN E-COMMERCE CO., LTD.]2Current NDC, 5 package rows20241209_8b30f623-6077-4f2e-8fa4-ce4a298953b5.zip

Products#

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

DailyMed product names page 1 of 1 · 23 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
83391-00483391-004-02, 83391-004-03, 83391-004-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 20 matching rows.

Name, UNII, Kind table
NameUNIIKind
ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER (60000 MPA.S)8Z5ZAL5H3VIACT
WATER059QF0KO0RIACT
ALOE VERA LEAFZY81Z83H0XIACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
CETETH-10 PHOSPHATE4E05O5N49GIACT
CYCLOMETHICONE 50THT5PCI0RIACT
DIHEXADECYL PHOSPHATE2V6E5WN99NIACT
DIMETHICONE92RU3N3Y1OIACT
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE)9E4CO0W6C5IACT
EDETATE DISODIUM ANHYDROUS8NLQ36F6MMIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
GLYCERYL STEARATE SEFCZ5MH785IIACT
HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (100000 MPA.S AT 1.5%)86FQE96TZ4IACT
LAVENDER OILZBP1YXW0H8IACT
ISOHEXADECANE918X1OUF1EIACT
PHENOXYETHANOLHIE492ZZ3TIACT
ALCOHOL3K9958V90MIACT
AMINOMETHYLPROPANOLLU49E6626QIACT
STEARETH-2153J3F32P58IACT
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
AUVON Pain Relief Roll-onLIDOCAINESHENZHEN YUWEN E-COMMERCE CO., LTD.8b30f623-6077-4f2e-8fa4-ce4a298953b52024-12-08WarningsExact identifier
ndc (package): 83391-004-01
ndc (package): 83391-004-03
ndc (package): 83391-004-02
ndc (product): 83391-004
ndc11 (package): 83391000402
ndc11 (package): 83391000403
ndc11 (package): 83391000401
spl id: 28c4811e-8c81-4626-e063-6294a90a6bc2
spl set id: 8b30f623-6077-4f2e-8fa4-ce4a298953b5

Reported adverse events (FAERS/openFDA)#

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