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 CunningPac, EZM Distributions,LLC. 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 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

GINKGO BILOBA LEAF OIL

PANAX GINSENG ROOT OIL

ARNICA MONTANA

THYMUS VULGARIS LEAF

WATER

ALCOHOL

SODIUM POLYACRYLATE (8000 MW)

DIMETHICONE 200

ETHYLHEXYLGLYCERIN

INDICATIONS & USAGE

Instant relief for:

Arthritis

Backache

Bruises

Cramps

Sprains

Strains

WHEN USING THIS PRODUCT:

* Avoid contact with eyes or micous 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 Poisen Control Center right away.

ACTIVE INGREDIENT

Menthol 2 %

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

EZ MASSAGER 4  EXTRA STRENGTH
menthol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71633-004
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
GINKGO BILOBA LEAF OIL (UNII: Y5967KO1JH)
SODIUM POLYACRYLATE (8000 MW) (UNII: 285CYO341L)
WATER (UNII: 059QF0KO0R)
ALCOHOL (UNII: 3K9958V90M)
DIMETHICONE 200 (UNII: RGS4T2AS00)
ARNICA MONTANA (UNII: O80TY208ZW)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
PANAX GINSENG ROOT OIL (UNII: P9T4K47OM0)
THYMUS VULGARIS LEAF (UNII: GRX3499643)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71633-004-01	12 in 1 CARTON	08/01/2017
1		12 mL in 1 CANISTER; Type 0: Not a Combination Product

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

Labeler - CunningPac (539075187)

Registrant - EZM Distributions,LLC (080627876)

Establishment
Name	Address	ID/FEI	Business Operations
CunningPac		539075187	manufacture(71633-004)