HYDROGEN PEROXIDE SOLUTION [WINCO FOODS, LLC]

HYDROGEN PEROXIDE SOLUTION [WINCO FOODS, LLC]
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NDC 67091-101-32
Set ID 87d3d78b-9a0a-4dbf-b0aa-198e28141252
Category HUMAN OTC DRUG LABEL
Packager WinCo Foods, LLC
Generic Name
Product Class
Product Number
Application Number PART333A
  • Active ingredient

    Hydrogen peroxide (stabilized) 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 the 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 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 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, then spit out
    • use up to 4 times daily after meals and at bedtime
  • Other information

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

  • Inactive ingredient

    purified water

  • SPL UNCLASSIFIED SECTION

    DISTRIBUTED BY:
    WINCO FOODS, LLC, BOISE, ID 83704
    COMMENTS & QUESTIONS? 800-824-1706 WWW.WINCOFOODS.COM

  • principal display panel

    DO NOT USE IF PRINTED SEAL UNDER CAP IS BROKEN OR MISSING

    WinCo Foods

    3% Hydrogen Peroxide

    TOPICAL SOLUTION U.S.P

    FIRST AID ANTISEPTIC

    ORAL DEBRIDING AGENT

    For treatment of minor cuts and abrasions

    For use as a gargle or rinse

    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:67091-101
    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:67091-101-32946 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/15/1989
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A07/15/1989
    Labeler - WinCo Foods, LLC (056098817)
    Registrant - Vi-Jon, LLC (790752542)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vi-Jon, LLC790752542manufacture(67091-101)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vi-Jon, LLC088520668manufacture(67091-101)

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