EZ MASSAGER 4 EXTRA STRENGTH- menthol gel

Ez Massager 4 by

Drug Labeling and Warnings

Ez Massager 4 by is a Otc medication manufactured, distributed, or labeled by BlackPort Distribution, EZM Distributions, LLC, Cunningpac CC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

DOSAGE & ADMINISTRATION

• Massage into painful area until thoroughly absorbed into skin
• Repeat as necessary but not more than 3 to 4 times per day

WARNINGS

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 sypmtoms persist for more than 7 days
• Symptons clear up and occur again within a few days
• Excessive skin irritation occurs
• You are pregnant or breast feeding

INACTIVE INGREDIENT

Ginkgo biloba leaf oil

Panax ginseng root oil

Arnica Montana

Ethylhexylglycerin

Thymus vulgaris leaf

Water

Alcohol

Dimethicone 200

Sodium polyacrylate (8000 mw)

INDICATIONS & USAGE

Instant relief for:

Arthritis

Backache

Bruises

Cramps

Sprains

Strains

WHEN USING THIS PRODUCT:

• Avoid contact with eyes or mucous membranes
• Do not bandage tightly

PURPOSE

Topical Analgesic

KEEP OUT OF REACH OF CHILDREN

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

ACTIVE INGREDIENT

Menthol, 2%

PRINCIPAL DISPLAY PANEL

Ez Massager 4

INGREDIENTS AND APPEARANCE

EZ MASSAGER 4  EXTRA STRENGTH
menthol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71555-004
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	4 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
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
Shape	FREEFORM (Gel)	Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71555-004-02	100 mL in 1 CANISTER; Type 0: Not a Combination Product	08/01/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	08/01/2017

Labeler - BlackPort Distribution (539179900)

Registrant - EZM Distributions, LLC (080627876)

Establishment
Name	Address	ID/FEI	Business Operations
Cunningpac CC		539075187	manufacture(71555-004)