Label: MEDICATED LIP BALM- camphor (natural), menthol and phenol stick 

  • NDC Code(s): 0363-6080-01, 0363-6080-02
  • Packager: Walgreen Co
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

NOTE: Most over the counter (OTC) are not reviewed and approved by the 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 11/13

If you are a consumer or patient please visit this version.

  • Active ingredients

    Camphor, 1.7%

    Menthol, 0.7%

    Phenol, 0.4%

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  • Purpose

    External Analgesic

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  • Uses

    • temporarily relieves pain and itching commonly associated with fever blisters and cold sores
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  • Warnings

    For external use only

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  • WHEN USING

    When using this product keep out of eyes.  Rinse with water to remove.

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  • STOP USE

    Stop use and ask a doctor

    • if rash occurs
    • symptoms last for more than 7 days or clear up and occur agin within a few days
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  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.  If swallowed, get medical help or contact a Poison Control Center right away. Close
  • Directions

    • adults and children 2 years of age and older, apply to lips not more than 3 to 4 times daily
    • children under 2 years of age: ask a doctor
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  • Inactive ingredients

    Alum, beeswax, cocoa butter, flavor, lanolin, petrolatum, salicylic acid

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  • INGREDIENTS AND APPEARANCE
    MEDICATED LIP BALM 
    medicated lip balm stick stick
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:0363-6080
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    CAMPHOR (NATURAL) (CAMPHOR (NATURAL)) CAMPHOR (NATURAL) 1.7 mg  in 1 g
    MENTHOL (MENTHOL) MENTHOL 0.7 mg  in 1 g
    PHENOL (PHENOL) PHENOL 0.4 mg  in 1 g
    Inactive Ingredients
    Ingredient Name Strength
    ALUM, POTASSIUM  
    WHITE WAX  
    COCOA BUTTER  
    LANOLIN  
    PETROLATUM  
    SALICYLIC ACID  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0363-6080-02 2 in 1 BLISTER PACK
    1 NDC:0363-6080-01 4 g in 1 CONTAINER
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part348 10/30/2013
    Labeler - Walgreen Co (008965063)
    Registrant - Lee Pharmaceuticals (056425432)
    Establishment
    Name Address ID/FEI Business Operations
    Lee Pharmaceuticals 056425432 manufacture(0363-6080)
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