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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  • FOR EXTERNAL USE ONLY.
  • AVOID CONTACT WITH EYES.

MENTHOL 4%

PURPOSE

PAIN RELIEF

KEEP OUT OF REACH OF CHILDREN

  • PROVIDES TINGLING SENSATION AND PAIN RELIEF

  • APPLY 1 OR 2 SPRAYS TO THE PENIS AND ALLOW A SHORT TIME TO TAKE EFFECT.

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 DRUGItem Code (Source)NDC:53389-039
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A, MENTHOL - UNII:L7T10EIP3A) MENTHOL4 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:53389-039-2130 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product12/03/201201/16/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34812/03/201201/16/2018
Labeler - MEGASOL COSMETIC GMBH (344152855)
Registrant - MEGASOL COSMETIC GMBH (344152855)
Establishment
NameAddressID/FEIBusiness Operations
MEGASOL COSMETIC GMBH344152855manufacture(53389-039)

Revised: 1/2018
Document Id: 885194d9-985c-4aad-b36a-8706fa1b0132
Set id: 40fcb1b4-65a3-45d9-95b7-ca58c4bd741d
Version: 3
Effective Time: 20180116
 
MEGASOL COSMETIC GMBH