HYDROGEN PEROXIDE SOLUTION [SUPERVALU, INC]

HYDROGEN PEROXIDE SOLUTION [SUPERVALU, INC]
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NDC 41163-871-43, 41163-871-45
Set ID 8a44aa29-58d6-4971-b572-4579f03ed227
Category HUMAN OTC DRUG LABEL
Packager UNFI
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 ares of the body
    • longer than 1 week
  • Askd 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 antiseptic:
    •clean the affected area
    •apply 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 and children 2 years of age and over:
    • mix with equal amount of water
    • swish around in the mouth over the affected area for at least 1 minute and then spit out
    • use up to 4 times daily after meals and at bedtime or as directed by a dentist or doctor.

    • children under 12 years of age should be supervised in the use of this product
    • children under 2 years of age: consult a dentist or 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

    Distributed by UNFI
    EDEN PRARIE, MN 55344
    CONTACT US AT 1-877-932-7948
    www.supervalu-ourownbrands.com

  • PRINCIPAL DISPLAY PANEL

    NDC 41163-871-43

    EQUALINE

    3% USP

    hydrogen peroxide topical solution

    first aid antseptic

    oral debriding agent

    for treatment of minor cuts & abrasions

    for use as a gargle

    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:41163-871
    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:41163-871-43473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product01/14/2005
    2NDC:41163-871-45946 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product01/14/2005
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A01/14/2005
    Labeler - UNFI (006961411)
    Registrant - Vi-Jon, LLC (790752542)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vi -Jon, LLC790752542manufacture(41163-871)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vi -Jon, LLC088520668manufacture(41163-871)