FDA.reportPublic FDA data

Pain Relieving Roll-On

Manufacturer
Safetec of America, Inc.
Effective date
2024-02-05
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:08:34

Label at a glance#

ProductPain Relieving Roll-On
Active ingredientMENTHOL, UNSPECIFIED FORM
Label structure9 sections

Indications and uses

Temporary relief of minor aches and pains of muscles and joints.

Dosage and administration

For adults and children 2 years of age and older: Shake well and apply to affected area not more than 3-4 times daily. Will not stain clothing. For children under 2 years of age, consult a doctor.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

USP Menthol 7%

Purpose

OTC - PURPOSE SECTION

Topical Analgesic

Uses

INDICATIONS & USAGE SECTION

Temporary relief of minor aches and pains of muscles and joints.

Warnings

WARNINGS SECTION

For external use only. Flammable.

Keep away from flame. 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. Avoid contact with eyes. Do not apply to open wounds or damaged skin. Do not bandage tightly.

Consult a doctor if excessive skin irritation occurs, or if you are prone to allergic reactions to salicylates, including aspirin. If condition worsens, if symptoms persist for more than 7 days or clear up and recur again within a few days, discontinue use of this product and consult a doctor.

Directions

DOSAGE & ADMINISTRATION SECTION

For adults and children 2 years of age and older: Shake well and apply to affected area not more than 3-4 times daily. Will not stain clothing. For children under 2 years of age, consult a doctor.

Other Information

OTHER SAFETY INFORMATION

Store at room temperature.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Eucalyptus Oil, Glycerin, Isopropyl Alcohol, Methyl Salicylate, Purified Water, Tea Tree Oil, Xanthan Gum.

Principal Display Panel - 3 oz. Bottle Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Safetec

PAIN RELIEVING

ROLL-ON

FAST-ACTING MUSCLE RELIEF

with Tea Tree & Eucalyptus Oils

Reorder No. 58003

3 fl. oz. (88ml) • Topical Analgesic

Principal Display Panel - 3 oz. Bottle Label
Principal Display Panel - 3 oz. Bottle Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
311509menthol 7 % Topical GelPSN2
311509menthol 0.07 MG/MG Topical GelSCD2
311509menthol 7 % Topical GelSY2

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
61010-1550-12024-02-13C16284748780-11030e365-516c-111a-e063-dadaa90a10e261010-1550-1, Pain Relieving Roll-on
61010-1550-12024-01-30C16284748780-11030e365-516c-111a-e063-dadaa90a10e261010-1550-1, Pain Relieving Roll-on

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61010-1550-1Pain Relieving Roll-On88 mL in 1 BOTTLEGEL882

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61010-1550PAIN RELIEVING ROLL-ON (MENTHOL, UNSPECIFIED FORM) GEL [SAFETEC OF AMERICA, INC.]2Current NDC, Legacy NDC, 1 package rows20240214_80118260-9c88-402d-9a90-ecfe62b4b54f.zip

Products#

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

DailyMed product names page 1 of 1 · 9 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
61010-155061010-1550-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

Name, UNII, Kind table
NameUNIIKind
EUCALYPTUS OIL2R04ONI662IACT
GLYCERINPDC6A3C0OXIACT
ISOPROPYL ALCOHOLND2M416302IACT
METHYL SALICYLATELAV5U5022YIACT
WATER059QF0KO0RIACT
TEA TREE OILVIF565UC2GIACT
XANTHAN GUMTTV12P4NEEIACT
MENTHOL, UNSPECIFIED FORML7T10EIP3AACTIB

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
Pain Relieving Roll-OnMENTHOL, UNSPECIFIED FORMSafetec of America, Inc.80118260-9c88-402d-9a90-ecfe62b4b54f2024-02-05WarningsExact identifier
ndc (package): 61010-1550-1
ndc (product): 61010-1550
ndc11 (package): 61010155001
spl id: 10a91ff8-4d59-15dd-e063-6394a90a3aad
spl set id: 80118260-9c88-402d-9a90-ecfe62b4b54f

Reported adverse events (FAERS/openFDA)#

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