DYNAREX HP 3 (HYDROGEN PEROXIDE) LIQUID [DYNAREX CORPORATION]

DYNAREX HP 3 (HYDROGEN PEROXIDE) LIQUID [DYNAREX CORPORATION]
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NDC 67777-306-01, 67777-306-02
Set ID 3bb8420e-8539-4118-b7ac-3bc6f4b50170
Category HUMAN OTC DRUG LABEL
Packager Dynarex Corporation
Generic Name
Product Class
Product Number
Application Number PART356
  • 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)

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