Label: BLISTER BALM- menthol 1% salve

  • 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 November 6, 2018

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  • PURPOSE

    External analgesic

  • ACTIVE INGREDIENT

    Active Ingredients

    Menthol 1%

    Purpose

    External Analgesic - cold sore or fever blister treatment

  • Uses:

    For relief of pain and itching associated with cold sore and fever blister outbreaks.

    Intense and immediate blocking of cold sore and gever blister symptoms.

  • Warnings

    For external use only.

    Keep out of reach of children.

    If swallowed, get medical help or contact a Poison Control Center right away.

  • KEEP OUT OF REACH OF CHILDREN

    keep out of reach of children. If swallowed get medical help or contact a poison control center immediately. (1-800-222-1222)

  • STOP USE

    Stop use and ask doctor if condition worsen or if symptoms persist for more than 7 days or clear up and occur again within a few days.

    When using this product avoid contact with the eyes

    keep out of Reach of children. If swallowed, get medical help or contact a poison control center immediately. (1-800-222-1222)

  • Directions

    • Adults and children 2 years of age and older. Apply to the afftected area not more than 3 to 4 times daily.
    • Children under 2 years of age: consult a doctor

  • Inactive Ingredients

    camphor

    clove (syzygium aromaticum) leaf oil

    eucalyptus globulus leaf oil

    hydrolyzed jojoba esters

    isopropyl jojobate

    jojoba (simmondsia chinensis) esters

    jojoba alcohols

    lemon balm (melissa officinalis) oil

    peppermint (menthe piperita) oil

    rose geranium (pelargonium graveolens) oil

  • PRINCIPAL DISPLAY PANEL

    LABEL

  • INGREDIENTS AND APPEARANCE
    BLISTER BALM 
    menthol 1% salve
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70996-003
    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
    EUCALYPTUS GLOBULUS LEAF (UNII: S546YLW6E6)  
    HYDROLYZED JOJOBA ESTERS (ACID FORM) (UNII: UDR641JW8W)  
    LEMON BALM OIL (UNII: MJ76269K9S)  
    ALPROSTADIL ISOPROPYL ESTER (UNII: 8THV3YDD6A)  
    CLOVE LEAF OIL (UNII: VCA5491KVF)  
    PELARGONIUM ROSEUM OIL (UNII: XSN2Q85DC6)  
    PEPPERMINT OIL (UNII: AV092KU4JH)  
    HYDROGENATED JOJOBA OIL (UNII: 7F674YQ5SO)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70996-003-012.6 g in 1 TUBE; Type 0: Not a Combination Product12/21/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34812/21/2016
    Labeler - Floratech Botanicals, LLC (805985686)
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