Label: HYDROGEN PEROXIDE 3 PERCENT- hydrogen peroxide liquid

  • NDC Code(s): 61715-119-16, 61715-119-32
  • Packager: Preferred Plus (Kinray)
  • 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 June 29, 2015

If you are a consumer or patient please visit this version.

  • Active ingredient

    Hydrogen peroxide 3%

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  • Purpose

    first aid antiseptic/oral debriding agent

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  • 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
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  • Warnings

    For external use only.

    Do not use

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

    Ask 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 (1-800-222-1222) right away.

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  • Directions

    For use as a first aid antiseptic:

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

    For use as an oral debriding agent (oral rinse):

    • adults and children 2 years of age and over:
      • mix with an equal amount of water
      • swish around in the mouth over affected area for at least 1 minute and then spit out. Do not swallow.
      • use up to 4 times daily after meals and at bedtime or as directed by a dentist or doctor
    • children under 12 years should be supervised in the use of this product
    • children under 2 years of age: consult a dentist or doctor
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  • Other information

    • Keep tightly closed and in a dark place at room temperature.
    • Do not shake bottle. Hold away from face when opening.
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  • Inactive ingredient

    purified water

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  • Princiapl Display Panel

    HYDROGEN PEROXIDE 3% U.S.P

    FIRST AID ANTISEPTIC

    ORAL DEBRIDING AGENT

    FOR EXTERNAL USE ONLY

    PREFERRED PLUS, PREFERRED PLUS ++++ and the PREFERRED PLUS logo are trademarks and/or registered trademarks of Kinray LLC.All other marks are property of their respective owners,

    Questions or comments?

    Call 1-877-753-3935 Monday-Friday 9AM-5PM EST

    Distributed by: Kinray LLC.

    152-35 Tenth Avenue

    Whitestone, NY 11357.

    TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL AROUND OR UNDER CAP IS BROKEN OR MISSING.

    FL OZ (mL)

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  • Package Label

    Hydrogen Peroxide 3%

    Preferred Plus Hydrogen Peroxide 3%

     

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  • INGREDIENTS AND APPEARANCE
    HYDROGEN PEROXIDE  3 PERCENT
    hydrogen peroxide liquid
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:61715-119
    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:61715-119-16 473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    2 NDC:61715-119-32 946 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC MONOGRAPH NOT FINAL part356 05/31/2015
    Labeler - Preferred Plus (Kinray) (012574513)
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