FDA.reportPublic FDA data

Pain Relief Roll-On

Manufacturer
Sagely Enterprises Inc. | Verde Cosmetic Labs, LLC
Effective date
2021-11-19
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:45:01

Label at a glance#

ProductPain Relief Roll-On
Active ingredientMENTHOL
Label structure7 sections

Indications and uses

temporarily relieves the minor aches and pains of muscles and joints associated with: arthritis sprains muscle strains bruises

Dosage and administration

Use only as directed Adults and children over 12 years: apply a thin layer to affected area massage into painful area repeat as necessary, but no more than 3 to 4 times daily Children 12 years or younger: ask a doctor.

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Menthol 10%

Purpose

OTC - PURPOSE SECTION

Menthol 10%.................Topical analgesic

Uses

INDICATIONS & USAGE SECTION

temporarily relieves the minor aches and pains of muscles and joints associated with:

  • arthritis
  • sprains
  • muscle strains
  • bruises

Warnings

WARNINGS SECTION

For external use only.

OTC - DO NOT USE SECTION

Do not use

  • on wounds, or damaged, broken, or irritated skin
  • with a heating pad

OTC - WHEN USING SECTION

When using this product

  • avoid contact with eyes or mucous membranes
  • do not bandage tightly

OTC - STOP USE SECTION

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.

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breastfeeding, ask a health professional 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 right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • Use only as directed

Adults and children over 12 years:

  • apply a thin layer to affected area
  • massage into painful area
  • repeat as necessary, but no more than 3 to 4 times daily
  • Children 12 years or younger: ask a doctor.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Water, Propanediol, Capryloyl Glycerin/Sebacic Acid Copolymer, Coco-Caprylate, Glyceryl Stearate, Glyceryl Stearate Citrate, Diheptyl Succinate, Glycerin, Lauryl Glucoside, Polyglyceryl-2 Dipolyhydroxystearate, Microcrystalline Cellulose, Cellulose Gum, Phytic Acid, Leuconostoc/Radish Root Ferment Filtrate, Boswellia Serrata Resin Extract, Polyglyceryl-6 Caprylate, Polyglyceryl-4 Caprate, Polyglyceryl-4 Cocoate, Polyglyceryl-6 Ricinoleate, Polyglyceryl-4 Laurate/Sebacate, Polyglyceryl-6 Caprylate/Caprate, Camphor, Arnica Montana Flower Extract, Aloe Barbadensis Leaf Extract, Xanthan Gum, Lavender (Lavandula Hybrida) Oil, Peppermint (Mentha Piperita) Oil, Caprylyl Glyceryl Ether, Caprylhydroxamic Acid

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Sagely Naturals

Pain Relief Roll-On

Instant Cooling

With 10% Menthol

95% Natural Ingredients

2 FL OZ / 60 ML

11

22

11

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1600976menthol 10 % Topical SolutionPSN2
1600976menthol 100 MG/ML Topical SolutionSCD2
1600976menthol 10 % Topical SolutionSY2

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
82075-420-052024-01-30C16284748780-11030e365-4244-111a-e063-dadaa90a10e2Pain Relief Roll-On
82075-420-202024-01-30C16284748780-11030e365-4244-111a-e063-dadaa90a10e2Pain Relief Roll-On

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
82075-420-05Pain Relief Roll-On51 g in 1 CYLINDERLIQUID512
82075-420-05Pain Relief Roll-On1 in 1 CARTONLIQUID12
82075-420-20Pain Relief Roll-On60 g in 1 CYLINDERLIQUID602
82075-420-20Pain Relief Roll-On1 in 1 CARTONLIQUID12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82075-420PAIN RELIEF ROLL-ON (MENTHOL) LIQUID [SAGELY ENTERPRISES INC.]2Legacy NDC, 4 package rows20211121_c6283ab0-8244-b8f3-e053-2a95a90a7bef.zip

Products#

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

DailyMed product names page 1 of 1 · 28 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
82075-42082075-420-20, 82075-420-05

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 27 matching rows.

Name, UNII, Kind table
NameUNIIKind
LAVENDER OILZBP1YXW0H8IACT
PEPPERMINT OILAV092KU4JHIACT
LEUCONOSTOC/RADISH ROOT FERMENT FILTRATED2QHA03458IACT
ARNICA MONTANAO80TY208ZWIACT
MENTHOLL7T10EIP3AACTIB
GLYCERINPDC6A3C0OXIACT
LAURYL GLUCOSIDE76LN7P7UCUIACT
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIEDK679OBS311IACT
BOSWELLIA SERRATA RESIN OIL5T1XCE6K8KIACT
PROPANEDIOL5965N8W85TIACT
POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE9229XJ4V12IACT
MICROCRYSTALLINE CELLULOSEOP1R32D61UIACT
POLYGLYCERYL-6 CAPRYLATEDGV8R54VG7IACT
POLYGLYCERYL-4 CAPRATE3N873UN885IACT
POLYGLYCERYL-6 RICINOLEATE8X57R183N7IACT
CAMPHOR (NATURAL)N20HL7Q941IACT
ALOE VERA LEAFZY81Z83H0XIACT
XANTHAN GUMTTV12P4NEEIACT
WATER059QF0KO0RIACT
CAPRYLOYL GLYCERIN/SEBACIC ACID COPOLYMER (2000 MPA.S)N7YC58165TIACT
COCO-CAPRYLATE4828G836N6IACT
GLYCERYL STEARATE CITRATEWH8T92A065IACT
GLYCERYL MONOSTEARATE230OU9XXE4IACT
DIHEPTYL SUCCINATE057N7SS26YIACT
FYTIC ACID7IGF0S7R8IIACT
CAPRYLYL GLYCERYL ETHERMI97BW74XZIACT
CAPRYLHYDROXAMIC ACIDUPY805K99WIACT

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
d12a5d19-fd12-1ae9-e053-2995a90a2434c6283ab0-8244-b8f3-e053-2a95a90a7bef2021-11-19WarningsExact identifier
spl id: d12a5d19-fd12-1ae9-e053-2995a90a2434
spl set id: c6283ab0-8244-b8f3-e053-2a95a90a7bef

Reported adverse events (FAERS/openFDA)#

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