MAJOR CAMPHOR AND PHENOL - antiseptic liquid 
Major Pharmaceuticals

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.

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Drug Facts

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

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

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)

Revised: 8/2012
Document Id: 1daa463f-7e91-47cb-a16d-7a95ca295b2e
Set id: 9282885f-b364-439b-b91b-7fcf4f734121
Version: 3
Effective Time: 20120817
 
Major Pharmaceuticals