FDA.reportPublic FDA data

DiolPure Menthol 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 Menthol Pain Relief Cream
Active ingredientCAMPHOR (SYNTHETIC), MENTHOL
Label structure8 sections

Indications and uses

for temporary relief of minor aches and pains of muscles and joints associated with: simple backache arthritis strains bruises

Dosage and administration

Adults and children 12 years of age and older: Apply to affected area not more than 3 to 4 times daily 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 ingredients

OTC - ACTIVE INGREDIENT SECTION

Menthol USP 12%

Camphor 6%

Purpose

OTC - PURPOSE SECTION

Menthol USP 12%.....................Topical Analgesic

Camphor 6%.............................Topical Analgesic

Uses

INDICATIONS & USAGE SECTION

for temporary relief of minor aches and pains of muscles and joints associated with:

  • simple backache
  • arthritis
  • strains
  • bruises

Warnings

WARNINGS SECTION

For external use only

OTC - DO NOT USE SECTION

Do not use

  • on damaged or broken skin

OTC - WHEN USING SECTION

When using this product

  • do not bandage tightly
  • avoid contact with eyes

OTC - STOP USE SECTION

Stop use and ask doctor if

  • condition worses or persists
  • rash develops

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 not more than 3 to 4 times daily
  • 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

Arnica Montana, Calendula Officinalis, Cannabidiol, Carbomer, Citric Acid, Ethyl Alcohol, Methyl Glucose Dioleate, Methylsulfonylmethane (MSM), Organic Medium-Chain Triglyceride (MCT), Coconut Oil, Purified Water, Sodium Hydroxide

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

DiolPure

Menthol 12%

Pain Relief Cream

500MG CBD to moisturize skin

Menthol 12%

For temporary relief of minor aches and pains

Net Wt. 2 oz (56.7 g)

11

22

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
82093-001-012024-01-30C16284748780-11030e365-4fb1-111a-e063-dadaa90a10e2DiolPure Menthol Pain Relief Cream

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
82093-001-01DiolPure Menthol Pain Relief Cream56.7 g in 1 BOTTLE, PUMPCREAM56.71
82093-001-01DiolPure Menthol Pain Relief Cream1 in 1 CARTONCREAM11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82093-001DIOLPURE MENTHOL PAIN RELIEF CREAM (MENTHOL, CAMPHOR) CREAM [DIOLPURE, LLC]1Legacy NDC, 2 package rows20210710_c6b3d442-9943-5e01-e053-2995a90a4513.zip

Products#

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

DailyMed product names page 1 of 1 · 16 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
82093-00182093-001-01

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
CAMPHOR (SYNTHETIC)5TJD82A1ETACTIB
CANNABIDIOL19GBJ60SN5IACT
CALENDULA OFFICINALIS FLOWERING TOP18E7415PXQIACT
DIMETHYL SULFONE9H4PO4Z4FTIACT
SODIUM HYDROXIDE55X04QC32IIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE0A5MM307FCIACT
ALCOHOL3K9958V90MIACT
METHYL GLUCOSE DIOLEATEFA9KFJ4Z6PIACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
MENTHOLL7T10EIP3AACTIB
ARNICA MONTANAO80TY208ZWIACT
WATER059QF0KO0RIACT
COCONUT OILQ9L0O73W7LIACT

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
c6b3d3e9-ded9-16ff-e053-2a95a90ad972c6b3d442-9943-5e01-e053-2995a90a45132021-07-09WarningsExact identifier
spl id: c6b3d3e9-ded9-16ff-e053-2a95a90ad972
spl set id: c6b3d442-9943-5e01-e053-2995a90a4513

Reported adverse events (FAERS/openFDA)#

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