Dr. Tobey's Pain Relieving Spray

Manufacturer
Pain Relieving Spray Inc. | Safetec of America, Inc.
Effective date
2024-08-09
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 00:58:06

Label at a glance#

ProductPain Relief
Active ingredientMENTHOL
Label structure8 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#

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.

Warning

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.

OTC - DO NOT USE SECTION

Do not apply to open wounds or damaged skin. Do not bandage tightly.

OTC - ASK DOCTOR SECTION

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

Pain Relieving Spray, 4oz (118.3ml) . Topical Analgesic

Water, Isopropyl Alcohol, Glycerol, Eucalyptus Leaf Oil, Wintergreen Leaf Oil, Peppermint Oil, Coconut Oil.

Labeling

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Principal Display PanelPrincipal Display PanelPain Relieving Spray, 4fl.oz. (118.3mL0, Topical Analgesic
Menthol 7%,
Eucalyptus Oil, Glycerin, Isopropyl Alcohol, Wintergreen Oil, Purified Water, Tea Tree Oil
Pain Relieving Spray Inc., Bend, OR 97702-1971

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1086713menthol 7 % Topical SprayPSN1
1086713menthol 70 MG/ML Topical SpraySCD1
1086713menthol 7 % Topical SpraySY1

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
84638-8201-1Pain Relief0.059 L in 1 BOTTLE, SPRAYAEROSOL, SPRAY0.0591

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
84638-8201PAIN RELIEF (MENTHOL) AEROSOL, SPRAY [PAIN RELIEVING SPRAY INC.]1Current NDC, 1 package rows20250331_1f44466f-044f-70fe-e063-6294a90ad575.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
84638-820184638-8201-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 8 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
Pain ReliefMENTHOLPain Relieving Spray Inc.1f44466f-044f-70fe-e063-6294a90ad5752024-08-09WarningsExact identifier
ndc (package): 84638-8201-1
ndc (product): 84638-8201
ndc11 (package): 84638820101
spl id: 1f44466f-0450-70fe-e063-6294a90ad575
spl set id: 1f44466f-044f-70fe-e063-6294a90ad575

Reported adverse events (FAERS/openFDA)#

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