EZ MASSAGER 4 EXTRA STRENGTH- menthol gel 
BlackPort Distribution

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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WARNING: For external use only

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

ASK A DOCTOR BEFORE USE IF:

Ginkgo biloba leaf oil

Panax ginseng root oil

Arnica Montana

Ethylhexylglycerin

Thymus vulgaris leaf

Water

Alcohol

Dimethicone 200

Sodium polyacrylate (8000 mw)

Instant relief for:

Arthritis

Backache

Bruises

Cramps

Sprains

Strains

WHEN USING THIS PRODUCT:

Topical Analgesic

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

Menthol, 2%

Ez Massager 4 Ez Massager 4

EZ MASSAGER 4  EXTRA STRENGTH
menthol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71555-004
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL4 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
THYMUS VULGARIS LEAF (UNII: GRX3499643)  
GINKGO BILOBA LEAF OIL (UNII: Y5967KO1JH)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
ALCOHOL (UNII: 3K9958V90M)  
DIMETHICONE 200 (UNII: RGS4T2AS00)  
SODIUM POLYACRYLATE (8000 MW) (UNII: 285CYO341L)  
PANAX GINSENG ROOT OIL (UNII: P9T4K47OM0)  
ARNICA MONTANA (UNII: O80TY208ZW)  
WATER (UNII: 059QF0KO0R)  
Product Characteristics
Color    Score    
ShapeFREEFORM (Gel) Size
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:71555-004-02100 mL in 1 CANISTER; Type 0: Not a Combination Product08/01/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34808/01/2017
Labeler - BlackPort Distribution (539179900)
Registrant - EZM Distributions, LLC (080627876)
Establishment
NameAddressID/FEIBusiness Operations
Cunningpac CC539075187manufacture(71555-004)

Revised: 11/2017
Document Id: 5f30b29f-913f-496c-e053-2991aa0a5d4e
Set id: 52a13c60-fe36-4596-e054-00144ff88e88
Version: 5
Effective Time: 20171130
 
BlackPort Distribution