Label: CHAPICE CAMPHOR PHENOL GEL- camphor, phenol gel

  • 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 July 29, 2013

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  • Active ingredient

    Camphor 10.8%, Phenol 4.7%

  • Purpose

    External Analgesic

  • Keep Out of Reach of Children

    If swallowed, get medical help or contact a Poison Control Center immediately. Do not induce vomiting before contacting medical help or a Poison Control Center. For adults and children over 2 years of age.

  • Uses

    For the temporary relief of pain and itching associated with cold sores and fever blisters. First Aid to help prevent infection.

  • Warnings

    For external use only.

    Do not use over large areas of the body or with a bandage. Ask a doctor before use if you have a deep puncture wound, animal bites, or serious burns.

    When using this product: avoid contact with eyes. Rinse with water to remove. Seek medical help or contact a Poison Control Center.

    Stop use and consult a doctor if: conditions worsen or last more than 7 days, or if it clears up and returns again in a few days.

  • Directions

    Adults and children over 2 years clean the affected area and apply directly to a cold sore or fever blister 1 to 3 times daily. Do not bandage.

  • Inactive Ingredients

    Colloidal Silicon Dioxide, Eucalyptus Oil, Glycerin, Light Mineral Oil

  • Package/Label Principal Display Panel

    Front and Back of Blister Card
  • INGREDIENTS AND APPEARANCE
    CHAPICE CAMPHOR PHENOL GEL 
    camphor, phenol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63645-160
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET) CAMPHOR (SYNTHETIC)10.8 mg  in 1 g
    PHENOL (UNII: 339NCG44TV) (PHENOL - UNII:339NCG44TV) PHENOL4.7 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    LIGHT MINERAL OIL (UNII: N6K5787QVP) 77.75 mg  in 1 g
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4) 5.75 mg  in 1 g
    GLYCERIN (UNII: PDC6A3C0OX) 0.5 mg  in 1 g
    EUCALYPTUS OIL (UNII: 2R04ONI662) 0.500 mg  in 1 g
    Product Characteristics
    ColorYELLOWScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63645-160-041 g in 1 CONTAINER
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34603/15/2013
    Labeler - OraLabs (801824756)
    Registrant - OraLabs (801824756)
    Establishment
    NameAddressID/FEIBusiness Operations
    OraLabs801824756MANUFACTURE(63645-160) , LABEL(63645-160)
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