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 Type HUMAN OTC DRUG Item Code (Source) NDC:53389-039
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A, MENTHOL - UNII:L7T10EIP3A) MENTHOL 4 g  in 100 mL
Inactive Ingredients
Ingredient Name Strength
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
ARGININE (UNII: 94ZLA3W45F)  
WATER (UNII: 059QF0KO0R)  
CARBOMER 1342 (UNII: 809Y72KV36)  
CAPSICUM (UNII: 00UK7646FG)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
ARNICA MONTANA (UNII: O80TY208ZW)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:53389-039-21 30 mL in 1 BOTTLE, SPRAY
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part348 12/03/2012
Labeler - MEGASOL COSMETIC GMBH (344152855)
Registrant - MEGASOL COSMETIC GMBH (344152855)
Establishment
Name Address ID/FEI Business Operations
MEGASOL COSMETIC GMBH 344152855 manufacture(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