Label: BLOSSOM HP 3- hydrogen peroxide liquid

  • NDC Code(s): 61767-306-01, 61767-306-02
  • Packager: Blossom Pharmaceuticals
  • 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 January 31, 2014

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  • ACTIVE INGREDIENT

    Active Ingredient                                       Purpose

    Hydrogen peroxide 3% v/v                         Antiseptic

                                                                       Oral debriding agent

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  • 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.
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  • 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
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  • INDICATIONS & USAGE

    Do not use:

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

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  • 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

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  • OTHER INFORMATION

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

    Inactive Ingredient

    • Water
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  • PRINCIPAL DISPLAY PANEL

    Blossom Pharmaceuticals 3% Hydrogen Peroxide

    Hydrogen Peroxide BP.jpg

    HP 3

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  • INGREDIENTS AND APPEARANCE
    BLOSSOM HP 3 
    hydrogen peroxide liquid
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:61767-306
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    HYDROGEN PEROXIDE (UNII: BBX060AN9V) (HYDROGEN PEROXIDE - UNII:BBX060AN9V) HYDROGEN PEROXIDE 2.65 mL  in 100 mL
    Inactive Ingredients
    Ingredient Name Strength
    WATER (UNII: 059QF0KO0R)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:61767-306-01 118 mL in 1 BOTTLE
    2 NDC:61767-306-02 454 mL in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part356 01/29/2014
    Labeler - Blossom Pharmaceuticals (677381470)
    Establishment
    Name Address ID/FEI Business Operations
    Blossom Pharmaceuticals 677381470 manufacture(61767-306)
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