FDA.reportPublic FDA data

PURE PERSONAL All Natural Pain Relief Cream

Manufacturer
PURE PERSONAL CARE, LLC
Effective date
2023-11-06
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:59:02

Label at a glance#

ProductPURE PERSONAL All Natural Pain Relief Cream
Active ingredientMENTHOL
Label structure8 sections

Indications and uses

• For the temporary relief of minor aches and pains of muscles and joints, associated with simple backache, arthritis, strains, bruises, and sprains. 

Dosage and administration

• Adults and children 2 years of age and older: Apply to affected area not more than 3 to 4 times daily. • Children under 2 years of age: consult a doctor.

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Menthol 7.5 %

Purpose

OTC - PURPOSE SECTION

Topical Analgesic

Uses:

INDICATIONS & USAGE SECTION

• For the temporary relief of minor aches and pains of muscles and joints, associated with simple backache, arthritis, strains, bruises, and sprains. 

Warnings:

WARNINGS SECTION

For external use only.

Do not use

OTC - DO NOT USE SECTION

• on damaged or broken skin.

When using this product 

OTC - WHEN USING SECTION

• Avoid contact with the eyes • Do not bandage tightly.

Stop use and ask a doctor if

OTC - STOP USE SECTION

• rash or irritation develops and lasts • 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 to affected area not more than 3 to 4 times daily. • Children under 2 years of age: consult a doctor.

Other information:

SPL UNCLASSIFIED SECTION

• Protect the product in this container from excessive heat and direct sun.

Inactive ingredients:

INACTIVE INGREDIENT SECTION

Aqua (Deionized Water), Beeswax, Boswellia Carterii (Frankincense) Oil, Camphor, Cannabis Sativa (Hemp) Seed Oil, Caprylyl Glycol, Cetearyl Alcohol, Cetearyl Glucoside, Citric Acid, Citrus Aurantium Dulcis (Orange) Oil, Eucalyptus Globulus Oil, Eugenia Caryophyllus (Clove) Bud Oil, Glyceryl Laurate, Glyceryl Stearate, Glyceryl Undecylenate, Helianthus Annuus (Sunflower) Oil, Isopropyl Alcohol, Mangifera Indica (Mango) Butter, Mentha Piperita (Peppermint) Oil, Methyl Salicylate, Tocopherol (Vitamin E), Xanthan Gum.

Questions or comments?

OTC - QUESTIONS SECTION

419-461-9916

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label2Label2

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1091886menthol 7.5 % Topical CreamPSN2
1091886menthol 75 MG/ML Topical CreamSCD2
1091886menthol 7.5 % Topical CreamSY2

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
83072-374-00PURE PERSONAL All Natural Pain Relief Cream59 mL in 1 JARCREAM592

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
83072-374PURE PERSONAL ALL NATURAL PAIN RELIEF CREAM (MENTHOL) CREAM [PURE PERSONAL CARE, LLC]2Current NDC, Legacy NDC, 1 package rows20231106_8f3fb1d0-d238-4b4c-9816-7e335258d71d.zip

Products#

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

DailyMed product names page 1 of 1 · 22 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
83072-37483072-374-00

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
WATER059QF0KO0RIACT
YELLOW WAX2ZA36H0S2VIACT
FRANKINCENSE OIL67ZYA5T02KIACT
CANNABIS SATIVA SEED OIL69VJ1LPN1SIACT
CAPRYLYL GLYCOL00YIU5438UIACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
CETEARYL GLUCOSIDE09FUA47KNAIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
ORANGE OIL, COLD PRESSEDAKN3KSD11BIACT
EUCALYPTUS OIL2R04ONI662IACT
CLOVE OIL578389D6D0IACT
GLYCERYL LAURATEY98611C087IACT
GLYCERYL MONOSTEARATE230OU9XXE4IACT
HELIANTHUS ANNUUS FLOWERING TOPBKJ0J3D1BPIACT
ISOPROPYL ALCOHOLND2M416302IACT
MANGOI629I3NR86IACT
PEPPERMINT OILAV092KU4JHIACT
METHYL SALICYLATELAV5U5022YIACT
TOCOPHEROLR0ZB2556P8IACT
XANTHAN GUMTTV12P4NEEIACT
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
PURE PERSONAL All Natural Pain Relief CreamMENTHOLPURE PERSONAL CARE, LLC8f3fb1d0-d238-4b4c-9816-7e335258d71d2023-11-06WarningsExact identifier
ndc (package): 83072-374-00
ndc (product): 83072-374
ndc11 (package): 83072037400
spl id: 0976fa2b-1b24-140f-e063-6394a90a72a5
spl set id: 8f3fb1d0-d238-4b4c-9816-7e335258d71d

Reported adverse events (FAERS/openFDA)#

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