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 00:41:17

Label at a glance#

ProductAUVON Pain Relief Roll-on
Active ingredientMENTHOL
Label structure9 sections

Dosage and administration

Rub a thin film over the affected area not more than 3 to 4 times daily Wash hands after use

Storage and handling

Store it in a dry place at room temperature between 20-25 C (68-77F) and away from direct sunlight.

Label contents#

Full prescribing information#

MENTHOL AUVON Pain Relief Roll-on

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Menthol 4%

Purposes

OTC - PURPOSE SECTION

Topical Analgestic

Use

INDICATIONS & USAGE SECTION

Temporary relief from minor aches and pains of sore muscles and joints

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

  • 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

  • Rub a thin film over the affected area not more than 3 to 4 times daily
  • Wash hands after use

Storage

STORAGE AND HANDLING SECTION

Store it in a dry place at room temperature between 20-25 C (68-77F) and away from direct sunlight.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Aloe Barbadensis Leaf Juice, Arctium Lappa Extract, Arnica Montana Flower Extract, Boswellia Serrata Extract, Calendula Officinalis Flower Extract, Camellia Sinensis Leaf Extract, Camphor, Carbomer, FD&C Blue NO.1, FD&C Yellow No.5, Glycerin, Ilex Paraguariensis Leaf Extract, Isopropyl Alcohol, IsopropyI Myristate, Melissa Officinalis Leaf Extract, Methyl Methacrylate Crosspolymer, Aminomethyl Propanol, Tocopheryl Acetate, Water

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage description

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
283438menthol 4 % Topical SolutionPSN2
283438menthol 40 MG/ML Topical SolutionSCD2
283438menthol 4 % Topical SolutionSY2

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
83391-003-01AUVON Pain Relief Roll-on1 in 1 PACKAGESOLUTION12
83391-003-01AUVON Pain Relief Roll-on74 mL in 1 BOTTLESOLUTION742
83391-003-02AUVON Pain Relief Roll-on2 in 1 PACKAGESOLUTION22
83391-003-02AUVON Pain Relief Roll-on74 mL in 1 BOTTLESOLUTION742
83391-003-03AUVON Pain Relief Roll-on74 mL in 1 BOTTLESOLUTION742
83391-003-03AUVON Pain Relief Roll-on3 in 1 PACKAGESOLUTION32

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
83391-003AUVON PAIN RELIEF ROLL-ON (MENTHOL) SOLUTION [SHENZHEN YUWEN E-COMMERCE CO., LTD.]2Current NDC, 6 package rows20241209_df239c4d-af6a-41ca-baed-d0788782ce9f.zip

Products#

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

DailyMed product names page 1 of 1 · 21 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
83391-00383391-003-01, 83391-003-02, 83391-003-03

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
WATER059QF0KO0RIACT
GLYCERINPDC6A3C0OXIACT
ALOE VERA LEAFZY81Z83H0XIACT
ARCTIUM LAPPA WHOLE73070DU1LAIACT
ARNICA MONTANA FLOWEROZ0E5Y15PZIACT
INDIAN FRANKINCENSE4PW41QCO2MIACT
CALENDULA OFFICINALIS FLOWERP0M7O4Y7YDIACT
GREEN TEA LEAFW2ZU1RY8B0IACT
CAMPHOR (NATURAL)N20HL7Q941IACT
CARBOMER 9404Q93RCW27EIACT
FD&C BLUE NO. 1H3R47K3TBDIACT
FD&C YELLOW NO. 5I753WB2F1MIACT
ILEX PARAGUARIENSIS LEAF1Q953B4O4FIACT
ISOPROPYL ALCOHOLND2M416302IACT
ISOPROPYL MYRISTATE0RE8K4LNJSIACT
MELISSA OFFICINALIS LEAF50D2ZE9219IACT
POLY(METHYL METHACRYLATE; 450000 MW)Z47NNT4J11IACT
AMINOMETHYLPROPANOLLU49E6626QIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
MENTHOLL7T10EIP3AACTIB

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-onMENTHOLSHENZHEN YUWEN E-COMMERCE CO., LTD.df239c4d-af6a-41ca-baed-d0788782ce9f2024-12-08WarningsExact identifier
ndc (package): 83391-003-01
ndc (package): 83391-003-03
ndc (package): 83391-003-02
ndc (product): 83391-003
ndc11 (package): 83391000301
ndc11 (package): 83391000302
ndc11 (package): 83391000303
spl id: 28c451bc-3a8b-ae1d-e063-6294a90ad61c
spl set id: df239c4d-af6a-41ca-baed-d0788782ce9f

Reported adverse events (FAERS/openFDA)#

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