Dr. PAINE'S Pain Relief Cream

Manufacturer
DOCTOR PAINE'S MEDICAL, LLC
Effective date
2023-11-11
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:00:09

Label at a glance#

ProductDr PAINES Pain Relief
Active ingredientMENTHOL
Label structure8 sections

Dosage and administration

Apply to affected area not more than three to four times daily. Adults and children two-years of age or older: consult a physician. Children under two-years of age:

Label contents#

Full prescribing information#

Active Ingredients:

OTC - ACTIVE INGREDIENT SECTION

Menthol 5.00%

OTC - PURPOSE SECTION

Topical Analgesic

Indications

INDICATIONS & USAGE SECTION

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

Warnings

WARNINGS SECTION

For external use only.

Avoid contact with eyes. 

If symptoms persist for more than seven days,discontinue use and consult physician.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, consult physician.

Do not 

OTC - DO NOT USE SECTION

apply to wounds damaged skin.

Do not bandage tightly.

If pregnant or breast feeding, 

OTC - PREGNANCY OR BREAST FEEDING SECTION

contact physician prior to use.

Directions

DOSAGE & ADMINISTRATION SECTION

Apply to affected area not more than three to four times daily. Adults and children two-years of age or older:

consult a physician. Children under two-years of age:

Additional information

SPL UNCLASSIFIED SECTION

store at room temperature.

Questions or comments?

OTC - QUESTIONS SECTION

Call toll free 1-855-537-7246 (1-855-5DRPAIN)

Other Ingredients:

INACTIVE INGREDIENT SECTION

Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Aqua (Deionized Water), Arnica Montana Flower Extract, Boswellia Serrata Extract, Bromelain, Cetearyl Olivate, Cetyl Alcohol, Eucalyptus Globulus Oil, Gluconolactone, Glycerin, Glyceryl Stearate, Helianthus Annuus (Sunflower) Oil, Magnesium Sulfate, Methylsulfonylmethane (MSM), Sodium Benzoate, Sorbitan Olivate, Stearic Acid, Xanthan Gum, Zemea (Corn) Propanediol.

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LabelLabel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1039690menthol 5 % Topical CreamPSN2
1039690menthol 50 MG/ML Topical CreamSCD2
1039690menthol 5 % Topical CreamSY2

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
78970-161-03Dr PAINES Pain Relief85 g in 1 TUBECREAM852
78970-161-03Dr PAINES Pain Relief1 in 1 BOXCREAM12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
78970-161DR PAINES PAIN RELIEF (MENTHOL) CREAM [DOCTOR PAINE'S MEDICAL, LLC]2Current NDC, Legacy NDC, 2 package rows20231112_79d2b332-051e-48c1-afe8-6d4468cd1878.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
78970-16178970-161-03

Ingredients#

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

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

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
Dr PAINES Pain ReliefMENTHOLDOCTOR PAINE'S MEDICAL, LLC79d2b332-051e-48c1-afe8-6d4468cd18782023-11-11WarningsExact identifier
ndc (package): 78970-161-03
ndc (product): 78970-161
ndc11 (package): 78970016103
spl id: 09e235ab-ce28-ad20-e063-6294a90a90a3
spl set id: 79d2b332-051e-48c1-afe8-6d4468cd1878

Reported adverse events (FAERS/openFDA)#

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