EZ MASSAGER 2 ORIGINAL- menthol gel

Ez Massager 2 by

Drug Labeling and Warnings

Ez Massager 2 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

Aqua/distilled/deionized

Rectified Alcohol

Arnica water-soluble

Beneficial Herbal Extract

Perservative 9010

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 2

INGREDIENTS AND APPEARANCE

EZ MASSAGER 2  ORIGINAL
menthol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71555-002
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	2 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
ARNICA MONTANA (UNII: O80TY208ZW)
GINKGO BILOBA LEAF OIL (UNII: Y5967KO1JH)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
WATER (UNII: 059QF0KO0R)
ALCOHOL (UNII: 3K9958V90M)
DIMETHICONE 200 (UNII: RGS4T2AS00)
SODIUM POLYACRYLATE (8000 MW) (UNII: 285CYO341L)
PANAX GINSENG ROOT OIL (UNII: P9T4K47OM0)
THYMUS VULGARIS LEAF (UNII: GRX3499643)

Product Characteristics
Color	white (Topical Gel)	Score
Shape	FREEFORM	Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71555-002-01	100 mL in 1 CANISTER; Type 0: Not a Combination Product	08/31/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	08/31/2017

Labeler - BlackPort Distribution (539179900)

Registrant - EZM Distributions, LLC (080627876)

Establishment
Name	Address	ID/FEI	Business Operations
CUNNINGPAC CC		539075187	manufacture(71555-002)