MAJOR CAMPHOR AND PHENOL (ANTISEPTIC) LIQUID [MAJOR PHARMACEUTICALS]

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MAJOR CAMPHOR AND PHENOL (ANTISEPTIC) LIQUID [MAJOR PHARMACEUTICALS]
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NDC 00904-7851-6, 00904-7851-7
Set ID 9282885f-b364-439b-b91b-7fcf4f734121
Category HUMAN OTC DRUG LABEL
Packager Major Pharmaceuticals
Generic Name
Product Class
Product Number
Application Number PART348
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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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