Label: EROS IRON MAN- menthol spray 

  • Label RSS
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

NOTE: Most over the counter (OTC) are not reviewed and approved by the FDA. However, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated 12/12

If you are a consumer or patient please visit this version.

  • WARNINGS

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

    MENTHOL 4%

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  • PURPOSE

    PURPOSE

    PAIN RELIEF

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  • KEEP OUT OF REACH OF CHILDREN

    KEEP OUT OF REACH OF CHILDREN

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  • INDICATIONS & USAGE

    • PROVIDES TINGLING SENSATION AND PAIN RELIEF
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  • DOSAGE & ADMINISTRATION

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

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

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  • INGREDIENTS AND APPEARANCE
    EROS IRON MAN 
    menthol spray
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:53389-039
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    MENTHOL (MENTHOL and MENTHOL) MENTHOL 4 g  in 100 mL
    Inactive Ingredients
    Ingredient Name Strength
    METHYLISOTHIAZOLINONE  
    ARGININE  
    WATER  
    CARBOMER 1342  
    CAPSICUM  
    PROPYLENE GLYCOL  
    ALOE VERA LEAF  
    ARNICA MONTANA  
    PHENOXYETHANOL  
    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)
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