Label: HYDROGEN PEROXIDE FIRST AID ANTISEPTIC- hydrogen peroxide liquid

  • NDC Code(s): 53329-981-06, 53329-981-25
  • Packager: Medline Industries, Inc.
  • 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 June 6, 2016

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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  • 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
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  • 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 puncture wounds, animal bites, or serious burns

    Stop use and ask a doctor if

    • 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.

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  • Directions

    First aid antiseptic:

    • Clean the affected area
    • Apply a small amount of product on the area 1 to 3 times daily
    • 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 under 2 years of age: consult a dentist, doctor
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  • Other information

    Keep tightly closed. Protect from freezing, avoid excessive heat. Do not shake bottle. Hold away from face when opening.

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  • Inactive ingredients

    purified water

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  • Principal Display Panel - Packet

    Medline Hydrogen Peroxide 3% PDP

    Medline

    NDC: 53329-981-06

    Hydrogen

    Peroxide

    3%

    First aid antiseptic

    Oral debriding agent

    Product sealed

    For your protection

    16 FL OZ

    (1 PT) 473 mL

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  • INGREDIENTS AND APPEARANCE
    HYDROGEN PEROXIDE  FIRST AID ANTISEPTIC
    hydrogen peroxide liquid
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:53329-981
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    HYDROGEN PEROXIDE (UNII: BBX060AN9V) (HYDROGEN PEROXIDE - UNII:BBX060AN9V) HYDROGEN PEROXIDE 3 mL  in 100 mL
    Inactive Ingredients
    Ingredient Name Strength
    WATER (UNII: 059QF0KO0R)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:53329-981-06 473 mL in 1 BOTTLE; Type 0: Not a Combination Product 01/01/2007
    2 NDC:53329-981-25 3780 mL in 1 JUG; Type 0: Not a Combination Product 01/01/2007
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part333A 01/01/2007
    Labeler - Medline Industries, Inc. (025460908)
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