HYDROGEN PEROXIDE SOLUTION [CARDINAL HEALTH]

HYDROGEN PEROXIDE SOLUTION [CARDINAL HEALTH]
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NDC 63517-450-26, 63517-450-34, 63517-450-43
Set ID 4263a70a-7669-45e2-ad93-ba357ae0a6cd
Category HUMAN OTC DRUG LABEL
Packager Cardinal Health
Generic Name
Product Class
Product Number
Application Number PART333A
  • Active ingredient

    Hydrogen peroxide (stabilized) 3%

  • purpose

    First Aid Antiseptic

    Oral debriding agent

  • Use

    • 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 occassional sore mouth

  • Warnings

    For external use only

  • Do Not Use

    • in the eyes or apply over large areas of the body
    • longer than 1 week
  • Ask a doctor before use if you have

    deep or pucture 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 right away

  • Directions

    First Aid Antiseptic:

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

    Oral Debriding Agent: 

    • adults, children over 2 years of age
    • mix with equal amount of water
    • swish around in the mouth over 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 dentist or doctor
  • Other information

    Keep tightly closed and at controlled room temperature.  Do not shake bottle.  Hold away from face when opening

  • Inactive ingredient

    water

  • SPL UNCLASSIFIED SECTION

    2015 Cardinal Health.  All Rights Reserved

    CARDINAL HEALTH and the Cardinal Health

    LOGO are trademarks or registered trademarks of Cardinal Health.

    Distributed by: Cardinal Health

    Waukegan, IL 60085 USA

    cardinalhealth.com 05/15

  • principal display panel

    NDC 63517-450-43

    Hydrogen Peroxide 3%

    first aid antiseptic

    oral debriding agent

    DO NOT USE IF PACKAGE OPENED OR DAMAGED

    TEMPERATURE LIMITATION 68°F - 77°F 20°C - 25°C

    Not Made with Natural Rubber Latex

    For Individual, Professional, and Hospital Use

    Cat. AS-HPL16

    Distributed by: Cardinal Health

    Waukegan, IL 60085 USA

    cardinalhealth.com 05/15

    2015 Cardinal Health. All Rights Reserved.

    CARDINAL HEALTH and the Cardinal Health

    LOGO are trademarks of Cardinal Health.

    CardinalHealth

    16 FL OZ (1 PT) 473 mL

    image description

  • INGREDIENTS AND APPEARANCE
    HYDROGEN PEROXIDE 
    hydrogen peroxide solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63517-450
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    HYDROGEN PEROXIDE (UNII: BBX060AN9V) (HYDROGEN PEROXIDE - UNII:BBX060AN9V) HYDROGEN PEROXIDE30 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63517-450-26118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/01/2015
    2NDC:63517-450-34237 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/01/2015
    3NDC:63517-450-43473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/01/2015
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A06/01/2015
    Labeler - Cardinal Health (961027315)
    Registrant - Vi-Jon, LLC (790752542)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vi-Jon, LLC790752542manufacture(63517-450)

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