Label: HYDROGEN PEROXIDE- hydrogen peroxide solution

  • NDC Code(s): 0869-0871-08, 0869-0871-34, 0869-0871-38, 0869-0871-43, view more
    0869-0871-45, 0869-0871-72
  • Packager: Vi-Jon
  • 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 September 24, 2015

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

  • Active ingredient

    Hydrogen peroxide (stabilized) 3%

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  • purpose

    First Aid Antiseptic

    Oral Debriding agent

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  • Use

    • first aid to help prevent the risk of infection in monor cuts, scrapes and burns
    • aids in the removal of phlegm, mucus, or the other secretions associated with ocasional sore mouth
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  • Warnings

    For external use  only

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  • Do Not Use

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

    deep or pucture wounds, animal bites or serious burns

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  • 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
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  • Keep out of reach of children

    If swallowed, get medical help or contact a Poison Control Center right away

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  • Directions

    First aid antiseptic:

    • clean the affected area
    • apply a small amound 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 equal amount of water
    • swish aroud in the mouth over the affected area for at least 1 minute
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  • Other information

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

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  • Inactive ingredients

    purified water

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  • Adverse reactions

    Distributed by:

    Vi-Jon

    One Swan Drive

    Smyrna, TN 37167

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  • Principal Display

    Swan

    HYDROGEN

    PEROXIDE

    Topical Solution USP

    • First Aid Antiseptic/Oral Debriding Agent
    • For Treatment of Minor Cus & Abrasions
    • For Use As a Gargle or Rinse

    Square bottle uses less plastic thatn a similarly sized round bottle  Recycleable ( if available in your area)

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

    16 FL OZ  (1 PT) 473 mL

    image description

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  • INGREDIENTS AND APPEARANCE
    HYDROGEN PEROXIDE 
    hydrogen peroxide solution
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:0869-0871
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    HYDROGEN PEROXIDE (UNII: BBX060AN9V) (HYDROGEN PEROXIDE - UNII:BBX060AN9V) HYDROGEN PEROXIDE 30 mg  in 1 mL
    Inactive Ingredients
    Ingredient Name Strength
    WATER (UNII: 059QF0KO0R)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0869-0871-34 236 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    2 NDC:0869-0871-43 473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    3 NDC:0869-0871-45 946 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    4 NDC:0869-0871-08 3790 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    5 NDC:0869-0871-72 295 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product
    6 NDC:0869-0871-38 295 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 part333A 07/15/1989
    Labeler - Vi-Jon (790752542)
    Registrant - Vi-Jon (790752542)
    Establishment
    Name Address ID/FEI Business Operations
    Vi-Jon 790752542 manufacture(0869-0871)
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