FDA.reportPublic FDA data

DiolPure Lidocaine Pain Relief Cream

Manufacturer
DiolPure, LLC | BioLyte Laboratories, LLC
Effective date
2021-07-09
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:41:21

Label at a glance#

ProductDiolPure Lidocaine Pain Relief Cream
Active ingredientLIDOCAINE
Label structure8 sections

Indications and uses

for temporary relief of minor joint and muscle pain

Dosage and administration

Adults and children 12 years of age and older: Apply to affected area every 6 to 8 hours, do not exceed 3 to 4 applications in a 24 hour period Before and after applying, wash hands with soap and water Children under 12 years of age: Consult a doctor

Storage and handling

store in a cool, dry place avoid direct sunlight

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Lidocaine HCL 4%

Purpose

OTC - PURPOSE SECTION

Lidocaine HCL 4%.................Topical Anesthetic

Uses

INDICATIONS & USAGE SECTION

for temporary relief of minor joint and muscle pain

Warnings

WARNINGS SECTION

For external use only

OTC - DO NOT USE SECTION

Do not use

  • on large areas of the body or on cut, irritated or swollen skin
  • on puncture wounds
  • for more than one week without consulting a doctor

OTC - WHEN USING SECTION

When using this product

  • use only as directed
  • do not allow contact with the eyes
  • do not bandage or apply local heat (such as heating pads) to the area of use

OTC - STOP USE SECTION

Stop use and ask doctor if

  • condition worsens
  • symptoms persist for more than 7 days

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breastfeeding, consult your doctor before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately.

Directions

DOSAGE & ADMINISTRATION SECTION

  • Adults and children 12 years of age and older: Apply to affected area every 6 to 8 hours, do not exceed 3 to 4 applications in a 24 hour period
  • Before and after applying, wash hands with soap and water
  • Children under 12 years of age: Consult a doctor

Other information

STORAGE AND HANDLING SECTION

  • store in a cool, dry place
  • avoid direct sunlight

Inactive ingredients

INACTIVE INGREDIENT SECTION

Aloe Barbadensis Leaf Extract, Cannabidiol, Caprylic/Capric Triglyceride, Caprylyl Glycol, Carbomer, Ethylhexylglycerin, Methyl Glucose Dioleate, Organic Medium-Chain Triglyceride (MCT), Coconut Oil, Purified Water, Sodium Hydroxide

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

DiolPure

Lidocaine 4%

Pain Relief Cream

Uscented

500MG CBD to moisturize skin

Lidocaine 4%

For temporary relief of minor joint and muscle pain

Net Wt. 2 oz (56.7 g)

11

22

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
LIDOCAINE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
4d7a96d5-8256-4268-9a6c-25ea66d321feProduct name120180814

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
82093-002-012024-01-30C16284748780-11030e365-5382-111a-e063-dadaa90a10e2DiolPure Lidocaine Pain Relief Cream

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
82093-002-01DiolPure Lidocaine Pain Relief Cream56.7 g in 1 BOTTLE, PUMPCREAM56.71
82093-002-01DiolPure Lidocaine Pain Relief Cream1 in 1 CARTONCREAM11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82093-002DIOLPURE LIDOCAINE PAIN RELIEF CREAM (LIDOCAINE HCL) CREAM [DIOLPURE, LLC]1Legacy NDC, 2 package rows20210710_c6b3df6f-f18e-7a5f-e053-2995a90a96b4.zip

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
82093-00282093-002-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Name, UNII, Kind table
NameUNIIKind
CAPRYLYL GLYCOL00YIU5438UIACT
CANNABIDIOL19GBJ60SN5IACT
WATER059QF0KO0RIACT
COCONUT OILQ9L0O73W7LIACT
SODIUM HYDROXIDE55X04QC32IIACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE0A5MM307FCIACT
METHYL GLUCOSE DIOLEATEFA9KFJ4Z6PIACT
LIDOCAINE98PI200987ACTIB
ALOE VERA LEAFZY81Z83H0XIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT

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
c6b3df6f-f18d-7a5f-e053-2995a90a96b4c6b3df6f-f18e-7a5f-e053-2995a90a96b42021-07-09WarningsExact identifier
spl id: c6b3df6f-f18d-7a5f-e053-2995a90a96b4
spl set id: c6b3df6f-f18e-7a5f-e053-2995a90a96b4

Reported adverse events (FAERS/openFDA)#

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