EROS IRON MAN- menthol spray 
MEGASOL COSMETIC GMBH

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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MENTHOL 4%

PURPOSE

PAIN RELIEF

KEEP OUT OF REACH OF CHILDREN

WATER, PROPYLENE GLYCOL, ALOE BARBARDENDENSIS, ARNICA MONTANA, CAPSICUM FRUTESCENS, PHENOXYETHANOL, METHYLISOTHIAZOLINIONE, CARBOMER, ARGININE

Eros Iron Man Spray_MUS00039 Drug Facts BoxEros Iron Man Spray_MUS00039 Label

EROS IRON MAN 
menthol spray
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:53389-039
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (MENTHOL and MENTHOL) MENTHOL4 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
METHYLISOTHIAZOLINONE 
ARGININE 
WATER 
CARBOMER 1342 
CAPSICUM 
PROPYLENE GLYCOL 
ALOE VERA LEAF 
ARNICA MONTANA 
PHENOXYETHANOL 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:53389-039-2130 mL in 1 BOTTLE, SPRAY
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34812/03/2012
Labeler - MEGASOL COSMETIC GMBH (344152855)
Registrant - MEGASOL COSMETIC GMBH (344152855)
Establishment
NameAddressID/FEIBusiness Operations
MEGASOL COSMETIC GMBH344152855manufacture(53389-039)

Revised: 12/2012
Document Id: 2fb52f26-a68c-4987-a556-cb0e155ecb1d
Set id: 40fcb1b4-65a3-45d9-95b7-ca58c4bd741d
Version: 2
Effective Time: 20121204
 
MEGASOL COSMETIC GMBH