Label: SHELO NABEL ARNICA GEL- menthol gel

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

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.

Drug Label Information

Updated October 15, 2019

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  • Active Ingredient U058

    Active Ingredient U058

  • Inactive Ingredient U058

    Inactive Ingredient U058

  • Warnings U058

    Warnings U058

  • KROC U058

    KROC U058

  • Administration U058

    Administration U058

  • Indications U058

    Indications

  • Uses U058

    Uses U058

  • Display Panel U058

    Display Panel

  • INGREDIENTS AND APPEARANCE
    SHELO NABEL ARNICA GEL 
    menthol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71424-1058
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL12.5 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71424-1058-1250 g in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product05/18/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34805/18/2017
    Labeler - Corporativo Serysi S de R L de C V (816628390)
    Registrant - Corporativo Serysi S de R L de C V (816628390)