HYDROGEN PEROXIDE 3 PERCENT (HYDROGEN PEROXIDE) LIQUID [PREFERRED PLUS (KINRAY)]

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HYDROGEN PEROXIDE 3 PERCENT (HYDROGEN PEROXIDE) LIQUID [PREFERRED PLUS (KINRAY)]
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NDC 61715-119-16, 61715-119-32
Set ID d031643d-70e3-4c76-a1cd-7f6e5d367465
Category HUMAN OTC DRUG LABEL
Packager Preferred Plus (Kinray)
Generic Name
Product Class
Product Number
Application Number PART356
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  • Active ingredient

    Hydrogen peroxide 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 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.

  • 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
  • Other information

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

    purified water

  • 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)

  • Package Label

    Hydrogen Peroxide 3%

    Preferred Plus Hydrogen Peroxide 3%

     
  • INGREDIENTS AND APPEARANCE
    HYDROGEN PEROXIDE  3 PERCENT
    hydrogen peroxide liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61715-119
    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:61715-119-16473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product05/31/201512/30/2022
    2NDC:61715-119-32946 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product05/31/201512/30/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart35605/31/201512/30/2022
    Labeler - Preferred Plus (Kinray) (012574513)
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