HYDROGEN PEROXIDE SOLUTION [SHOPKO STORES OPERATING CO, LLC]

HYDROGEN PEROXIDE SOLUTION [SHOPKO STORES OPERATING CO, LLC]
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NDC 37012-871-43, 37012-871-45
Set ID b9ee2b88-8ebd-416a-8c97-85188d4d4222
Category HUMAN OTC DRUG LABEL
Packager Shopko Stores Operating Co, 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, mucous, or 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 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

    First Aid

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

    Oral debriding agent adults and 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 use
    • children under 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 ingredient

    purified water

  • SPL UNCLASSIFIED SECTION

    Manufactured by Vi-Jon, LLC,  for Shopko Stores Operating Co.LLC

    Made in the USA www.shopko.com

  • principal display panel

    SHOPKO

    Hydrogen Peroxide 3% Topical Solution USP

    First Aid Antiseptic

    Oral Debriding Agent

    For Treatment of Minor Cuts and Abrasions

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

    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:37012-871
    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:37012-871-43473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product01/22/2009
    2NDC:37012-871-45946 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product01/22/2009
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A01/22/2009
    Labeler - Shopko Stores Operating Co, LLC (023252638)
    Registrant - Vi Jon, LLC (790752542)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vi-Jon, LLC790752542manufacture(37012-871)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vi-Jon, LLC088520668manufacture(37012-871)

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