HYDROGEN PEROXIDE SOLUTION [VI-JON]

HYDROGEN PEROXIDE SOLUTION [VI-JON]
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NDC 0869-0871-18, 0869-0871-43, 0869-0871-45, 0869-0871-72, 0869-0871-99
Set ID e0a07631-6770-48b3-bf7b-19f3f3965cd9
Category HUMAN OTC DRUG LABEL
Packager Vi-Jon, LLC
Generic Name
Product Class
Product Number
Application Number PART333A
  • Active ingredient

    Hydrogen peroxide (stablized) 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 secretionsassociated with occasional sore mouth
  • Warnings

    For external use only

  • Do not use

    • in the eyes or apply over large areas of the 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 right away.

  • Directions

    For First aid:
    • clean the affected area
    • spray a small amount of product on the affected area 1 to 3 times a day
    • may be covered with a sterile bandage
    • if bandaged, let dry first

    Oral debriding agent: adults, children over 2 years of age:

    • mix with an 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 2 years of age: consult a dentist, doctor
  • Other information

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

  • Inactive ingredients

    purified water

  • SPL UNCLASSIFIED SECTION

    Manufactured by: Vi-Jon, LLC., St. Louis, MO 63114

    Questions or Comments? 1-888-593-0593

    871.000/871AA

  • SPL UNCLASSIFIED SECTION

    Swan Hydrogen Peroxide Topical Solution USP

    First Aid Antiseptic/Oral Debriding Agent

    For treatment of minor cuts & abrasions

    For use as a gargle or rinse

    Square bottle uses less plastic than a similarly sized round bottle. Recyclable (if available in your area)

    SEALED WITH PRINTED NECKBAND FOR YOUR PROTECTION

    16 FL OZ (1 PT) 473 mL

    image description

  • principal display panel

    Do not use if printed seal under cap is broken or missing

    mountain falls

    for treatment of minor cuts and abrasions

    3% U.S.P. hydrogen peroxide topical solution USP

    first aid antiseptic

    oral debriding agent

    Made in the USA with US and foreign parts

    32 FL OZ (1 QT) 946 mL

    image description

  • INGREDIENTS AND APPEARANCE
    HYDROGEN PEROXIDE 
    hydrogen peroxide solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0869-0871
    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:0869-0871-72295 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product07/09/2017
    2NDC:0869-0871-43473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/09/2017
    3NDC:0869-0871-45946 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/09/2017
    4NDC:0869-0871-18118 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product07/09/2017
    5NDC:0869-0871-99237 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product07/09/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A07/09/2017
    Labeler - Vi-Jon, LLC (790752542)
    Registrant - Vi-Jon, LLC (790752542)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vi-Jon, LLC790752542manufacture(0869-0871)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vi-Jon, LLC088520668manufacture(0869-0871)