Label: HYDROGEN PEROXIDE - hydrogen peroxide solution

  • NDC Code(s): 76384-007-01
  • Packager: Worldwide Sales & Distribution Corp.
  • 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 August 25, 2011

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  • SPL UNCLASSIFIED SECTION

    Drug Facts Close
  • ACTIVE INGREDIENT

    Active ingredient
    Hydrogen peroxide 3%

    Purpose
    First aid antiseptic
    Oral debriding agent
    Close
  • 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
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  • 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
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  • 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
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  • 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 Close
  • INACTIVE INGREDIENT

    Inactive ingredient
    Purified water
    Close
  • Package Label
  • INGREDIENTS AND APPEARANCE
    HYDROGEN PEROXIDE  
    hydrogen peroxide solution
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:76384-007
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    HYDROGEN PEROXIDE (UNII: BBX060AN9V) (HYDROGEN PEROXIDE - UNII:BBX060AN9V) HYDROGEN PEROXIDE .3 kg  in 100 L
    Inactive Ingredients
    Ingredient Name Strength
    WATER (UNII: 059QF0KO0R)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:76384-007-01 .473 L in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part333A 08/25/2011
    Labeler - Worldwide Sales & Distribution Corp. (627014330)
    Establishment
    Name Address ID/FEI Business Operations
    Steller Mercantile Pvt. Ltd. 650493005 manufacture
    Close