Label: SHELO NABEL POMADA ARNICA- 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 U059

    Active Ingredient U059

  • Inactive Ingredient U059

    Inactive Ingredient U059

  • Warnings U059

    Warnings U059

  • Uses U059

    Uses U059

  • KROC U059

    KROC U059

  • Administration U059

    Admon U059

  • Indications U059

    Indications U059

  • Display Panel

    Display Panel U059

  • INGREDIENTS AND APPEARANCE
    SHELO NABEL POMADA ARNICA 
    menthol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71424-1059
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL, UNSPECIFIED FORM - UNII:L7T10EIP3A) MENTHOL, UNSPECIFIED FORM20 mg  in 1 g
    CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET) CAMPHOR (SYNTHETIC)30 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71424-1059-1140 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)