Label: TOPICAL EDGE- menthol lotion

  • 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 August 31, 2017

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  • DOSAGE & ADMINISTRATION

  • WARNINGS

  • INACTIVE INGREDIENT

  • INDICATIONS & USAGE

  • KEEP OUT OF REACH OF CHILDREN

  • PURPOSE

  • ACTIVE INGREDIENT

  • PRINCIPAL DISPLAY PANEL

    Topical Edge Label

  • INGREDIENTS AND APPEARANCE
    TOPICAL EDGE 
    menthol lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70458-500
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL0.5 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    JOJOBA OIL (UNII: 724GKU717M)  
    SORBIC ACID (UNII: X045WJ989B)  
    POLYGLYCERYL-4 OLEATE (UNII: 15B05TY4GX)  
    POLYGLYCERYL-4 STEARATE (UNII: VLC3W3U1PE)  
    WATER (UNII: 059QF0KO0R)  
    ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    PALM KERNEL OIL (UNII: B0S90M0233)  
    SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
    ALCOHOL (UNII: 3K9958V90M)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    HYDRATED SILICA (UNII: Y6O7T4G8P9)  
    LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
    POLOXAMER 407 (UNII: TUF2IVW3M2)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70458-500-02300 g in 1 TUBE; Type 0: Not a Combination Product09/25/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34809/25/2017
    Labeler - AmperSand Biopharma (080111681)
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