Label: DYNAREX HP 3- hydrogen peroxide liquid

  • Category: HUMAN OTC DRUG LABEL

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 January 29, 2014

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  • ACTIVE INGREDIENT

    Active Ingredient                                       Purpose

    Hydrogen peroxide 3% v/v                         Antiseptic

                                                                       Oral debriding agent

  • PURPOSE

    First aid to help prevent the risk of infection in:

    • minor cuts
    • scrapes
    • burns
    • aids in the removal of phlegm, mucus, or other secretions associated with occassional sore mouth.
  • WARNINGS

    • For external use only
    • Ask a doctor before use if you have deep puncture wounds, animal bites or serious burns.
    • Stop use and ask a doctor if condition persist or gets worse.
    • Sore mouth symptoms do not improve in 7 days
    • irritation, pain, or redness persists or worsens
    • swelling rash or fever develops
  • INDICATIONS & USAGE

    Do not use:

    • in the eyes or over large areas of the body
    • longer than 1 week
  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.

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

  • DOSAGE & ADMINISTRATION

    DIRECTIONS as a  First Aid Antiseptic:

    • clean the affected area
    • apply a small amount of this product on the affected area 1 to 3 times a day
    • may be covered with a sterile bandage
    • if bandaged let dry first

    DIRECTIONS as a Oral Debriding Agent:

    Adults, children over 2 years of age:

    • mix with an equal amount of water
    • swish around the mouth in the affected area for at least 1 minute, then spit out
    • use up to 4 times daily after meals and at bedtime
    • children under 12 years of age should be supervised in the use
    • children under 2 years of age consult a dentis or doctor

  • OTHER INFORMATION

    • keep tightly closed and at controlled room temperature.
    • do not shake bottle
    • Hold away from face when opening
  • INACTIVE INGREDIENT

    Inactive Ingredient

    • Water
  • PRINCIPAL DISPLAY PANEL

    DYNAREX 3% Hydrogen Peroxide

    Hydrogen Peroxide.jpg

    HP 3

  • INGREDIENTS AND APPEARANCE
    DYNAREX HP 3 
    hydrogen peroxide liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67777-306
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    HYDROGEN PEROXIDE (UNII: BBX060AN9V) (HYDROGEN PEROXIDE - UNII:BBX060AN9V) HYDROGEN PEROXIDE2.65 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:67777-306-01118 mL in 1 BOTTLE
    2NDC:67777-306-02454 mL in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35601/29/2014
    Labeler - Dynarex Corporation (008124539)
    Registrant - Dynarex Corporation (008124539)
    Establishment
    NameAddressID/FEIBusiness Operations
    Blossom Pharmaceuticals677381470manufacture(67777-306)