Label: CAMPHOR- SYNTHETIC AND PHENOL gel

  • 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 February 16, 2011

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  • ACTIVE INGREDIENT

    Active ingredient                                                                              Purpose
    Camphorated phenol (camphor 10.8% and phenoll 4.7%) .........................Pain reliever/antiseptic
  • PURPOSE

    Active ingredient                                                                              Purpose
    Camphorated phenol (camphor 10.8% and phenoll 4.7%) .........................Pain reliever/antiseptic

    Use
    - for the temporary relief of pain and itching associated with cold sores and fever blisters
    - first aid to help prevent infection

  • KEEP OUT OF REACH OF CHILDREN


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

    Do not induce vomiting before contacting medical help or a Poison Control Center.
  • INDICATIONS & USAGE

    Uses
    - for the temporary relief of pain and itching associated with cold sores and fever blisters
    - first aid to help prevent infection

  • WARNINGS

    Warnings
    For external use only.
    ______________________________________________________________________________

    Do not use
    - over large areas of the body - with a bandage
    ______________________________________________________________________________

    Ask a doctor before use if you have
    - a deep puncture wound - animal bites - serious burns

    ______________________________________________________________________________

    When using this product do not use in or near the eyes. If contact occurs rinse eyes
    thoroughly with water and obtain medical attention.
    ______________________________________________________________________________

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

    Keep out of reach of children. If swallowed get medical help or contact a Poison Control
    Center right away.
    Do not induce vomiting before contacting medical help or a Poison Control Center
  • DOSAGE & ADMINISTRATION


    Directions
    - adults and children two years and over:
     - clean the affected area
    - apply directly to teh cold sore or fever blister 1 to 3 times daily
    - Do not bandage

    Children under two years: ask a doctor
     
    Other information

    Store at room temperature. Avoid excessive heat.
    Close cover tightly after each use
  • INACTIVE INGREDIENT

    Inactive Ingredients colloided silicon dioxide, eucalyptus oil, glycerin, light mineral oil
  • PRINCIPAL DISPLAY PANEL


    label

  • INGREDIENTS AND APPEARANCE
    CAMPHOR (SYNTHETIC) AND PHENOL 
    camphor (synthetic) and phenol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59779-088
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET) CAMPHOR (SYNTHETIC)108 mg  in 1 g
    PHENOL (UNII: 339NCG44TV) (PHENOL - UNII:339NCG44TV) PHENOL47 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    MINERAL OIL (UNII: T5L8T28FGP)  
    EUCALYPTUS OIL (UNII: 2R04ONI662)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59779-088-436.5 g in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34805/19/2009
    Labeler - CVS (062312574)
    Registrant - Pharma Pac, LLC (140807475)
    Establishment
    NameAddressID/FEIBusiness Operations
    Pharma Pac, LLC140807475manufacture
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