Label: MEDICATED LIP BALM- medicated lip balm stick stick

  • Category: HUMAN OTC DRUG LABEL

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 15, 2013

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  • Active ingredients

    Camphor, 1.7%

    Menthol, 0.7%

    Phenol, 0.4%

  • Purpose

    External Analgesic

  • Uses

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

    For external use only

  • WHEN USING

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

  • 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
  • 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.
  • 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
  • Inactive ingredients

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

  • PRINCIPAL DISPLAY PANEL

    Card

  • PRINCIPAL DISPLAY PANEL

    Label

  • INGREDIENTS AND APPEARANCE
    MEDICATED LIP BALM 
    medicated lip balm stick stick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0363-6080
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CAMPHOR (NATURAL) (UNII: N20HL7Q941) (CAMPHOR (NATURAL) - UNII:N20HL7Q941) CAMPHOR (NATURAL)1.7 mg  in 1 g
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL0.7 mg  in 1 g
    PHENOL (UNII: 339NCG44TV) (PHENOL - UNII:339NCG44TV) PHENOL0.4 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    ALUM, POTASSIUM (UNII: 1L24V9R23S)  
    WHITE WAX (UNII: 7G1J5DA97F)  
    COCOA BUTTER (UNII: 512OYT1CRR)  
    LANOLIN (UNII: 7EV65EAW6H)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    SALICYLIC ACID (UNII: O414PZ4LPZ)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0363-6080-022 in 1 BLISTER PACK
    1NDC:0363-6080-014 g in 1 CONTAINER
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34810/30/2013
    Labeler - Walgreen Co (008965063)
    Registrant - Lee Pharmaceuticals (056425432)
    Establishment
    NameAddressID/FEIBusiness Operations
    Lee Pharmaceuticals056425432manufacture(0363-6080)
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