Label: MAJOR CAMPHOR AND PHENOL- antiseptic liquid

  • 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 August 17, 2012

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  • Active ingredient

    Camphorated phenol

    (camphor, 10.8% and phenol, 4.7%)

  • Purpose

    Pain reliever/antiseptic

  • USES

    • first aid to help reduce the risk of infection associated with minor cuts, scrapes, minor burns, and insect bites
    • for the temporary relief of pain and itching associated with minor burns, sunbrun, minor cuts, scrapes, fever blisters and cold sores
  • Warnings

    • for external use only
  • Do not use

    • in the eyes
    • or apply over large areas of the body
  • Ask a doctor before use if you have

    • deep or puncture wounds
    • animal bites
    • serious burns
  • When using this product

    • avoid contact with the eyes
    • do not bandage
  • Stop use and ask 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

  • Directions

    • clean the affected area
    • adults and children 2 years of age or older: apply a small amount of this product on the area 1 to 3 times daily
    • children under 2 years of age: consult a doctor
  • Inactive ingredients

    eucalyptus oil, light mineral oil

  • PRINCIPAL DISPLAY PANEL

    Major

    Camphor & Phenol

    Antiseptic Liquid

    1.5 fl. oz (44ml)

    label imageimage of label

    Major

    Camphor & Phenol

    Antiseptic Liquid

    1.5 fl. oz (44ml)

    carton imageimage of carton

  • INGREDIENTS AND APPEARANCE
    MAJOR CAMPHOR AND PHENOL 
    antiseptic liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:00904-7851
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET) CAMPHOR (SYNTHETIC)10.8 g  in 100 mL
    PHENOL (UNII: 339NCG44TV) (PHENOL - UNII:339NCG44TV) PHENOL4.7 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    EUCALYPTUS OIL (UNII: 2R04ONI662)  
    LIGHT MINERAL OIL (UNII: N6K5787QVP)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:00904-7851-61 in 1 CARTON
    1NDC:00904-7851-744 mL in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34805/09/2008
    Labeler - Major Pharmaceuticals (191427277)
    Registrant - Lee Pharmaceuticals (056425432)
    Establishment
    NameAddressID/FEIBusiness Operations
    Major Pharmaceuticals191427277label(00904-7851)
    Establishment
    NameAddressID/FEIBusiness Operations
    Lee Pharmaceuticals056425432pack(00904-7851) , manufacture(00904-7851)
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