EZ MASSAGER 4 EXTRA STRENGTH- menthol gel 
CunningPac

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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Massage into painful area until thoroughly absorbed into skin

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

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

GINKGO BILOBA LEAF OIL

PANAX GINSENG ROOT OIL

ARNICA MONTANA

THYMUS VULGARIS LEAF

WATER

ALCOHOL

SODIUM POLYACRYLATE (8000 MW)

DIMETHICONE 200

ETHYLHEXYLGLYCERIN

Instant relief for:

Arthritis

Backache

Bruises

Cramps

Sprains

Strains

WHEN USING THIS PRODUCT:

* Avoid contact with eyes or micous membranes

* Do not bandage tightly

Topical Analgesic

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

Menthol 2 %

ezmassager04

EZ MASSAGER 4  EXTRA STRENGTH
menthol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71633-004
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL2 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:71633-004-0112 in 1 CARTON08/01/2017
112 mL in 1 CANISTER; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34808/01/2017
Labeler - CunningPac (539075187)
Registrant - EZM Distributions,LLC (080627876)
Establishment
NameAddressID/FEIBusiness Operations
CunningPac539075187manufacture(71633-004)

Revised: 8/2017
Document Id: 576db6ba-c254-ebde-e053-2a91aa0aab51
Set id: 54d06c10-d139-1399-e054-00144ff8d46c
Version: 2
Effective Time: 20170823
 
CunningPac