Label: HYDROGEN PEROXIDE- hydrogen peroxide solution

  • Category: HUMAN OTC DRUG LABEL

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Drug Label Information

Updated August 25, 2011

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  • SPL UNCLASSIFIED SECTION

    Drug Facts
  • ACTIVE INGREDIENT

    Active ingredient
    Hydrogen peroxide 3%

    Purpose
    First aid antiseptic
    Oral debriding agent
  • INDICATIONS & USAGE

    Uses
    • first aid to help prevent the risk of infection in minor cuts, scrapes and burns
    • aid in the removal of phlegm, mucus or other secretions associated with occasional sore mouth
  • WARNINGS

    Warnings
    For external use only

    Do not use
    • in the eyes or apply over large areas of the body
    • more than one week

    Consult a doctor before use if you have animal bites or serious burns, deep or punctured wounds

    Stop use and ask a doctor if
    • the condition persists or gets worse
    • sore mouth symptoms do not improve in a week
    • pain redness or irritation persists or if you develop fever, rash or swelling

    Keep out of reach of children
    If swallowed seek professional assistance or contact a poison control center immediately
  • DOSAGE & ADMINISTRATION

    Directions
    First aid antiseptic
    •clean the affected area
    •apply a small amount of product on the affected area 1 to 3 times a day
    •may be covered with a sterile bandage
    •let dry first before using bandage

    Oral debriding agent (oral rinse)
    Adults and children 2 years of age and over:
    • mix with equal amount of water
    • swish around in the mouth over the affected area for at least 1 minute and then spit out
    • use up to 4 times daily after meals and at bedtime or as directed by a doctor or dentist

    • children under 2 years of age: consult a dentist or doctor
    • children under 12 years of age should be supervised in the use of this product
  • GENERAL PRECAUTIONS

    Other information
    Keep tightly closed in a dark place at controlled room temperature
    Do not shake bottle. Keep away from face when opening
  • INACTIVE INGREDIENT

    Inactive ingredient
    Purified water
  • Package Label

    image of principal display panel

  • INGREDIENTS AND APPEARANCE
    HYDROGEN PEROXIDE  
    hydrogen peroxide solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76384-007
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    HYDROGEN PEROXIDE (UNII: BBX060AN9V) (HYDROGEN PEROXIDE - UNII:BBX060AN9V) HYDROGEN PEROXIDE.3 kg  in 100 L
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:76384-007-01.473 L in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A08/25/2011
    Labeler - Worldwide Sales & Distribution Corp. (627014330)
    Establishment
    NameAddressID/FEIBusiness Operations
    Steller Mercantile Pvt. Ltd.650493005manufacture
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