Label: BUMOOLY-S- methyl salicylate solution

  • 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 May 16, 2014

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  • ACTIVE INGREDIENT

    methyl salicylate


  • INACTIVE INGREDIENT

    camphor, menthol, glycyrrhetic acid, diphenhydramine hcl, dibucaine hcl


  • PURPOSE

    aczema, dermatitis, erosion, miliaria, pruritus, pernio, insect bite, hives


  • KEEP OUT OF REACH OF CHILDREN

    keep out or reach of the children


  • INDICATIONS & USAGE

    apply to the affected area once to several times a day


  • WARNINGS

    avoid contact with eyes, if this product splashes in to your eyes, wash immediately with water


  • DOSAGE & ADMINISTRATION

    for external use only


  • PRINCIPAL DISPLAY PANEL

    package label
  • INGREDIENTS AND APPEARANCE
    BUMOOLY-S 
    methyl salicylate solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68994-2001
    Route of AdministrationTRANSDERMAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE3 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    MENTHOL (UNII: L7T10EIP3A)  
    CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET)  
    DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40)  
    DIBUCAINE HYDROCHLORIDE (UNII: Z97702A5DG)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68994-2001-150 mL in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34805/16/2014
    Labeler - Scott Holdings Co., Ltd. (689665651)
    Registrant - Scott Holdings Co., Ltd. (689665651)
    Establishment
    NameAddressID/FEIBusiness Operations
    Hyundai Pharmaceutical Co., Ltd.687874958manufacture(68994-2001)
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