Label: COLDSORE BOMB- menthol ointment

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph 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 2, 2020

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  • Active ingredients

    Menthol 1%

  • Purpose

    External analgesic

  • WARNINGS

  • Directions

    • Adults and children 2 years of age and older: Apply to the affected area not more than 5 times daily.
  • INDICATIONS & USAGE

  • Other Information

    Store at room temperature 68 to 77°F (20 to 25ºC).

  • Inactive Ingredients

    Cocoa Butter, Coconut Oil, Croton Lechleri, Grapeseed Oil, Lanolin, Peppermint Oil, Tea Tree Oil

  • Packaging

    menthol

  • INGREDIENTS AND APPEARANCE
    COLDSORE BOMB 
    menthol ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72883-020
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL1 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    LANOLIN (UNII: 7EV65EAW6H)  
    COCOA BUTTER (UNII: 512OYT1CRR)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    GRAPE SEED OIL (UNII: 930MLC8XGG)  
    PEPPERMINT OIL (UNII: AV092KU4JH)  
    CROTON LECHLERI RESIN (UNII: GGG6W25C63)  
    TEA TREE OIL (UNII: VIF565UC2G)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72883-020-011 in 1 BOX12/09/2019
    13.5 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34612/09/2019
    Labeler - Envisionate PSJ LLC (116959523)
    Registrant - Envisionate PSJ LLC (116959523)
    Establishment
    NameAddressID/FEIBusiness Operations
    Paket Corporation007774730manufacture(72883-020)
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