FDA.reportPublic FDA data

Ez Massager 4

Manufacturer
CunningPac | EZM Distributions,LLC
Effective date
2017-08-23
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 22:52:33

Label at a glance#

ProductEz Massager 4 Extra strength
Active ingredientMENTHOL
Label structure8 sections

Label contents#

Full prescribing information#

DOSAGE & ADMINISTRATION SECTION

Massage into painful area until thoroughly absorbed into skin

repeat as necessary but not more than 3 to 4 times per day

WARNINGS SECTION

WARNING: For external use only

DO NOT USE: On wounds or damaged skin with a heating pad

ASK A DOCTOR BEFORE USE IF:

* You have redness over the affected area

* Conditions Worsen or symptoms persisist for more than 7 days

* Symptoms clear up and occur again within a few days

* Excessive skin irratation occurs

* You are pregnant or breast feeding

INACTIVE INGREDIENT SECTION

GINKGO BILOBA LEAF OIL

PANAX GINSENG ROOT OIL

ARNICA MONTANA

THYMUS VULGARIS LEAF

WATER

ALCOHOL

SODIUM POLYACRYLATE (8000 MW)

DIMETHICONE 200

ETHYLHEXYLGLYCERIN

INDICATIONS & USAGE SECTION

Instant relief for:

Arthritis

Backache

Bruises

Cramps

Sprains

Strains

WHEN USING THIS PRODUCT:

* Avoid contact with eyes or micous membranes

* Do not bandage tightly

OTC - PURPOSE SECTION

Topical Analgesic

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

KEEP OUT OF REACH OF CHILDREN: If swallowed, get medical help or contact a Poisen Control Center right away.

OTC - ACTIVE INGREDIENT SECTION

Menthol 2 %

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

ezmassager04ezmassager04

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
71633-004-042020-01-31C16284748780-19d75b9d0-9b41-f424-e053-dadaa90a57ce54d06c10-d139-1399-e054-00144ff8d46c

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71633-004-01Ez Massager 4Extra strength12 in 1 CARTONGEL122
71633-004-01Ez Massager 4Extra strength12 mL in 1 CANISTERGEL122

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71633-004EZ MASSAGER 4 EXTRA STRENGTH (MENTHOL) GEL [CUNNINGPAC]22 package rows20170926_54d06c10-d139-1399-e054-00144ff8d46c.zip

Products#

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

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
71633-00471633-004-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Name, UNII, Kind table
NameUNIIKind
MENTHOLL7T10EIP3AACTIB
GINKGO BILOBA LEAF OILY5967KO1JHIACT
SODIUM POLYACRYLATE (8000 MW)285CYO341LIACT
WATER059QF0KO0RIACT
ALCOHOL3K9958V90MIACT
DIMETHICONE 200RGS4T2AS00IACT
ARNICA MONTANAO80TY208ZWIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
PANAX GINSENG ROOT OILP9T4K47OM0IACT
THYMUS VULGARIS LEAFGRX3499643IACT

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
576db6ba-c254-ebde-e053-2a91aa0aab5154d06c10-d139-1399-e054-00144ff8d46c2017-08-23WarningsExact identifier
spl id: 576db6ba-c254-ebde-e053-2a91aa0aab51
spl set id: 54d06c10-d139-1399-e054-00144ff8d46c

Reported adverse events (FAERS/openFDA)#

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