HYDROGEN PEROXIDE SOLUTION [GEISS, DESTIN & DUNN, INC]

HYDROGEN PEROXIDE SOLUTION [GEISS, DESTIN & DUNN, INC]
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NDC 50804-871-34, 50804-871-43, 50804-871-45
Set ID 2efcda54-b8b7-4266-89c0-7f686c7afdca
Category HUMAN OTC DRUG LABEL
Packager Geiss, Destin & Dunn, Inc
Generic Name
Product Class
Product Number
Application Number PART333A
  • Active ingredient

    Hydrogen peroxide (stabilized) 3%

  • Purpose

    First Aid Antiseptic

    Oral debriding agent

  • Use

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

    Oral Debriding Agent: 

    • adults, 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 the use
    • 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 sprayer tip away from face when opening.

  • Inactive ingredient

    purified water

  • SPL UNCLASSIFIED SECTION

    Distributed by:

    Geiss, Destin & Dunn, Inc

    Peachtree City, GA 30269

    www.valuelabels.com

  • principal display panel

    NDC 5804-871-34

    GoodSense

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

    Hydrogen Peroxide

    Topical Solution USP

    • First Aid Antiseptic
    • Oral Debriding Agent

    Drug Facts

    Active ingredient                               Purpose

    Hydrogen peroxide (Stablized) 3%     First aid antisepic, Oral debriding agent

    Distributed By:

    Geiss, Destin & Dunn, Inc

    Peachtree City, GA 30269

    www. valuelabels.com

    100% SATISFACTION GUARANTEED

    8 fl oz (239 mL)

    image description

  • INGREDIENTS AND APPEARANCE
    HYDROGEN PEROXIDE 
    hydrogen peroxide solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50804-871
    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:50804-871-34236 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/15/1992
    2NDC:50804-871-43473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/15/1992
    3NDC:50804-871-45946 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/15/1992
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A06/15/1992
    Labeler - Geiss, Destin & Dunn, Inc (076059836)
    Registrant - Vi-Jon, LLC (790752542)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vi-Jon, LLC790752542manufacture(50804-871)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vi-Jon, LLC088520668manufacture(50804-871)