FDA.reportPublic FDA data

VonaFlex Effective Pain Relief Topical Analgesic

Manufacturer
OPTIMAL LABORATORIES, LLC | Pure Source, LLC
Effective date
2026-01-28
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 01:35:18

Label at a glance#

ProductVonaFlex Effective Pain Relief Topical Analgesic
Active ingredientLIDOCAINE HYDROCHLORIDE
Label structure7 sections

Indications and uses

For temporary relief of pain

Dosage and administration

Adults and children 2 years of age and older: Apply a thin layer to the affected area and massage until the lotion is no longer visible,  up to three times a day. Children under 2 years of age: consult a doctor.

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Lidocaine hydrochloride 4%

Purpose

OTC - PURPOSE SECTION

Topical Analgesic

Uses:

INDICATIONS & USAGE SECTION

  • For temporary relief of pain

Warnings:

WARNINGS SECTION

For external use only

Do not use

OTC - DO NOT USE SECTION

  • in large quantities, particularly over raw surfaces or blistered areas

When using this product

OTC - WHEN USING SECTION

  • Avoid contact with the eyes

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days.

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.

If pregnant or breast-feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

Directions:

DOSAGE & ADMINISTRATION SECTION

  • Adults and children 2 years of age and older: Apply a thin layer to the affected area and massage until the lotion is no longer visible,  up to three times a day.
  • Children under 2 years of age: consult a doctor.

Other information:

SPL UNCLASSIFIED SECTION

  • Store at 20-25°C (68-77°F) and protect from moisture

Inactive ingredients:

INACTIVE INGREDIENT SECTION

Arnica Montana Extract, Caramel, Carbomer, Cetearyl Alcohol, Cetyl Esters, Disodium EDTA, Ethoxydiglycol, Ethyl Macadamiate, Ethylhexylglycerin, Glycerin, Helianthus Annuus (Sunflower) Seed Oil, Lavandula Angustifolia (Lavender) Flower Oil, Menthyl Lactate, PEG-40 Hydrogenated Castor Oil, Phenoxyethanol, Propylene Glycol, Scutellaria Baicalensis Root Extract, Tetrahydrodiferuloylmethane, Tocopheryl Acetate, Triethanolamine, Water (Aqua)

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Outer PackageOuter PackageInner PackageInner Package

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
87359-987-00VonaFlex Effective Pain Relief Topical Analgesic50 mL in 1 BOTTLECREAM501
87359-987-00VonaFlex Effective Pain Relief Topical Analgesic1 in 1 BOXCREAM11

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
87359-98787359-987-00

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 21 matching rows.

Name, UNII, Kind table
NameUNIIKind
ARNICA MONTANA WHOLEO80TY208ZWIACT
CARAMELT9D99G2B1RIACT
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE0A5MM307FCIACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
CETYL ESTERS WAXD072FFP9GUIACT
EDETATE DISODIUM7FLD91C86KIACT
DIETHYLENE GLYCOL MONOETHYL ETHERA1A1I8X02BIACT
ETHYL MACADAMIATEANA2NCS6V1IACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
GLYCERINPDC6A3C0OXIACT
SUNFLOWER OIL3W1JG795YIIACT
MENTHYL LACTATE, (-)-2BF9E65L7IIACT
POLYOXYL 40 HYDROGENATED CASTOR OIL7YC686GQ8FIACT
PHENOXYETHANOLHIE492ZZ3TIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
SCUTELLARIA BAICALENSIS ROOT7J95K7ID2SIACT
TETRAHYDRODIFERULOYLMETHANE00U0645U03IACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
TROLAMINE9O3K93S3TKIACT
WATER059QF0KO0RIACT
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
VonaFlex Effective Pain Relief Topical AnalgesicLIDOCAINE HYDROCHLORIDEOPTIMAL LABORATORIES, LLC0901244a-7d41-413a-b424-92a807532f282026-01-28WarningsExact identifier
ndc (package): 87359-987-00
ndc (product): 87359-987
ndc11 (package): 87359098700
spl id: 4974ca9f-b5f8-870d-e063-6294a90a26c5
spl set id: 0901244a-7d41-413a-b424-92a807532f28

Reported adverse events (FAERS/openFDA)#

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