HYDROGEN PEROXIDE 3 PERCENT (HYDROGEN PEROXIDE) LIQUID [NATIONAL DISTRIBUTION NETWORK (SMART CHOICE)]

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HYDROGEN PEROXIDE 3 PERCENT (HYDROGEN PEROXIDE) LIQUID [NATIONAL DISTRIBUTION NETWORK (SMART CHOICE)]
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NDC 53441-268-16
Set ID a955fbdb-a862-44d4-8ff2-482db50a35fc
Category HUMAN OTC DRUG LABEL
Packager National Distribution Network (Smart Choice)
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 doctor or dentist
  • 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

  • Principal Display Panel

    3% U.S.P

    Hydrogen Peroxide

    First Aid Antiseptic

    FL OZ (mL)

    Distributed by

    National Distribution Network

    P.O Box 875

    Melville, NY 11747-0875

    Questions or Comments?

    Call 1-877-753-3935

    Monday-Friday 9AM-5PM EST

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

  • Package Label

    Hydrogen peroxide 3%

    Smart Choice 3% Hydrogen Peroxide

     
  • INGREDIENTS AND APPEARANCE
    HYDROGEN PEROXIDE  3 PERCENT
    hydrogen peroxide liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53441-268
    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:53441-268-16473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product10/31/201412/31/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart35610/31/201412/31/2021
    Labeler - National Distribution Network (Smart Choice) (045099210)
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