Label: CVS CAMPHOR PHENOL GEL- camphor, phenol gel

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not 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 May 4, 2015

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  • Active ingredient

    Camphor (10.8%), Phenol (4.7%)

  • Purpose

    Pain reliever/antiseptic

  • 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.

  • 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 or puncture wound. Animal bites. Serious burns. When using this product do not use near the eye. If contact occurs, rinse eyes thoroughly with water and obtain medical attention.

  • Directions

    Adults and children 2 years or over: clean the affected area. Apply directly to the cold sore or fever blister 1 to 3 times daily. Do not bandage. Children under 2 years: ask a doctor.

  • Inactive Ingredients

    Eucalyptus, Glycerin, Mineral Oil, Silica.

  • Package/Label Principal Display Panel

    Back Panel of CVS Camphor Phenol Gel Box
  • INGREDIENTS AND APPEARANCE
    CVS CAMPHOR PHENOL GEL 
    camphor, phenol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69842-553
    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:69842-553-011 g in 1 CONTAINER; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34805/04/2015
    Labeler - CVS (062312574)
    Registrant - OraLabs, Inc. (801824756)
    Establishment
    NameAddressID/FEIBusiness Operations
    OraLabs, Inc.801824756MANUFACTURE(69842-553) , LABEL(69842-553)
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