FDA.reportPublic FDA data

PAINGEL ROLL-ON

Manufacturer
NACOR BUSINESS GROUP LLC
Effective date
2025-11-06
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 01:18:30

Label at a glance#

ProductPAINGEL ROLL-ON
Active ingredientMENTHOL
Label structure12 sections

Indications and uses

For temporary relief of minor aches and pains in muscles and joints.

Dosage and administration

Adults and children over 12 years of age • Apply a small amount on the affected area. • Massage in circular motion, let set for a few seconds. • Repeat as necessary, but no more than 3 to 4 times daily. Children under 12 years of age. Do not use, consult a doctor.

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Menthol ………………………………...…………………………….…. 3%

OTC - PURPOSE SECTION

Topical Analgesic

Uses

INDICATIONS & USAGE SECTION

For temporary relief of minor aches and pains in muscles and joints.

WARNINGS SECTION

• For external use only.

• Ask a doctor before use if you have redness over affected area.

OTC - WHEN USING SECTION


• Avoid contact with the eyes or mucous membranes.
• Do not apply to wounds or damaged skin.
• Do not apply to the irritated skin or if excessive irritation develops.
• Do not bandage tightly.
• Do not use with heating pad or device.
• Stop use and ask a doctor if condition worsens, or if symptoms persist for more than 7 days, or clear up and occur again within a few days.

If pregnant or breast-feeding

OTC - PREGNANCY OR BREAST FEEDING SECTION

Ask a health professional before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

Adults and children over 12 years of age

• Apply a small amount on the affected area.

• Massage in circular motion, let set for a few seconds.

• Repeat as necessary, but no more than 3 to 4 times daily.

Children under 12 years of age. Do not use, consult a doctor.

Other information

OTHER SAFETY INFORMATION

Store tightly closed in a dry place at controlled room temperature between 59°F-86° F(15°C-30° C).

INACTIVE INGREDIENT SECTION

Water (Aqua), Alcohol Denat, Propylene Glycol, Polysorbate 20, Glycerin, Arnica Montana Flower Extract, Polyacrylamide, C13-14 Isoparaffin, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Laureth-7, Sodium Hydroxide, Disodium EDTA, Benzyl Alcohol, Salicylic Acid, Sorbic Acid, FD&C Yellow No.6 (CI 15985).

Questions or comments?

OTC - QUESTIONS SECTION

Contact us +1-307-533-7345

PAINGEL ROLL-ON

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PG ROLL-ONPG ROLL-ON

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
259150menthol 3 % Topical GelPSN1
259150menthol 0.03 MG/MG Topical GelSCD1
259150menthol 3 % Topical GelSY1

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130755439009710GTIN-13: 0755439009710
EAN-13: 0755439009710
GTIN-12: 755439009710
UPC-A: 755439009710
GTIN storage (14 digits): 00755439009710		FD-04704 PAINGEL PAIN RELIEF ROLL-ON.jpg
QR code linkQR Codepaingelnbg.com/FD-04704 PAINGEL PAIN RELIEF ROLL-ON.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
dea2eded-d1e7-46bb-9a3d-f8dc20de6277Product name120190408
9869efd7-d6dd-0665-5b67-53adbe6ef15eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
85110-003-03PAINGEL ROLL-ON85 g in 1 BOTTLEGEL851

Products#

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

DailyMed product names page 1 of 1 · 18 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
85110-00385110-003-03

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 17 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
ALCOHOL3K9958V90MIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
MENTHOLL7T10EIP3AACTIB
POLYSORBATE 207T1F30V5YHIACT
GLYCERINPDC6A3C0OXIACT
ARNICA MONTANA FLOWEROZ0E5Y15PZIACT
POLYACRYLAMIDE (1500 MW)5D6TC4BRWVIACT
C13-14 ISOPARAFFINE4F12ROE70IACT
ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER (60000 MPA.S AT 1.0%)8Z5ZAL5H3VIACT
LAURETH-7Z95S6G8201IACT
SODIUM HYDROXIDE55X04QC32IIACT
EDETATE DISODIUM7FLD91C86KIACT
BENZYL ALCOHOLLKG8494WBHIACT
SALICYLIC ACIDO414PZ4LPZIACT
SORBIC ACIDX045WJ989BIACT
FD&C YELLOW NO. 6H77VEI93A8IACT

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
PAINGEL ROLL-ONMENTHOLNACOR BUSINESS GROUP LLC42fb0bdf-8bbd-bbe3-e063-6294a90a656c2025-11-06WarningsExact identifier
ndc (package): 85110-003-03
ndc (product): 85110-003
ndc11 (package): 85110000303
spl id: 42fb0be6-d7df-31e0-e063-6394a90ae4be
spl set id: 42fb0bdf-8bbd-bbe3-e063-6294a90a656c

Reported adverse events (FAERS/openFDA)#

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