Label: HYDROGEN PEROXIDE solution

  • NDC Code(s): 67732-871-43, 67732-871-45
  • Packager: Duane Reade
  • 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 March 11, 2022

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  • Active ingredient

    Hydrogen peroxide (stabilized) 3%

    Purpose

    First aid antiseptic/oral debriding agent

  • Uses

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

  • Warnings

    For external use only

    Do not use

    •in the eyes or apply over large areas of the body • longer than 1 week

    As a doctor before use if

    you have deep or puncture wounds, animal bites or serious burns

    Stop use and ask a doctor if

    • the condition persists or gets worse • sore mouth symptoms do not improve in 7 days • irritation, pain or redness persists or worsens • swelling, rash or fever develops

    Keep out of reach of children.

    If swallowed, get medical help or contact a Poison Control Center right away.

  • 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
    •if bandaged, let dry first

    Oral debriding agent 9oral rinse): adults and children 2 years of age and over:
    •mix with an 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 dentist or doctor

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

  • Other information

    keep tightly closed and at controlled room temperature.  Do not shake bottle.  Hold away from face when opening.

  • Inactive ingredient

    purified water

  • Questions?

    Call 1-800-910-6674

    871.000/871AA

  • PRINCIPAL DISPLAY PANEL

    Duane Reade

    hydrogen peroxide topical solution USP

    first aid antiseptic

    oral debriding agent

    for treatment of minor cuts and abrasions

    for use as a gargle or rinse

    Sealed with printed neckband for your protection

    16 FL OZ (1 PT) 473 mL

    image description

  • INGREDIENTS AND APPEARANCE
    HYDROGEN PEROXIDE 
    hydrogen peroxide solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67732-871
    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:67732-871-43.473 L in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product01/22/2009
    2NDC:67732-871-45.946 L in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product01/22/2009
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A01/22/2009
    Labeler - Duane Reade (011988995)
    Registrant - Vi-Jon, LLC (790752542)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vi-Jon, LLC790752542manufacture(67732-871)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vi-Jon, LLC088520668manufacture(67732-871)
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