CAMPHOR (SYNTHETIC) AND PHENOL GEL [CVS]

CAMPHOR (SYNTHETIC) AND PHENOL GEL [CVS]
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NDC 59779-088-43
Set ID c6459570-e458-47e5-aa01-fdf34f349adc
Category HUMAN OTC DRUG LABEL
Packager CVS
Generic Name
Product Class
Product Number
Application Number PART348
  • 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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