Q2 ORAL CARE KIT (HYDROGEN PEROXIDE) KIT [HALYARD HEALTH]

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  • Q2 ORAL CARE KIT (HYDROGEN PEROXIDE) KIT [HALYARD HEALTH]

Q2 ORAL CARE KIT (HYDROGEN PEROXIDE) KIT [HALYARD HEALTH]
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NDC 69697-983-01
Set ID 71d9d8eb-7ee4-46c1-a657-dc2b93ddf751
Category HUMAN OTC DRUG LABEL
Packager Halyard Health
Generic Name
Product Class
Product Number
Application Number PART356
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  • SPL UNCLASSIFIED SECTION

    Drug Facts

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  • Active Ingredient

    Hydrogen Peroxide 1.5%

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  • Purpose

    Oral Debriding Agent

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  • Uses

    • Aids in the removal of phlegm, mucus, or other secretions in the temporary relief of discomfort due to occasional sore throat and sore mouth.
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  • Warnings

    Stop use and ask a doctor if

    • Swelling, rash, or fever develop.
    • Severe or persistent sore throat or sore throat accompanied by high fever, headache, nausea, and vomiting occurs.

    • Do not use more than 2 days or administer to children under 3 years of age unless directed by a physician.

    Keep out of reach of children under 3 years of age.

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  • Directions

    • Topical dosage for adults and children 3 years of age and older is a rinse used no more than 4 times daily. For children under 3 years of age, there is no recommended dosage except under the advice and supervision of a dentist or doctor.
    • Use only under health care practitioners supervision.
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  • Other Information

    • Store at room temperature.
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  • Inactive Ingredients

    Purified Water, Glycerin, Flavor, Sodium Saccharin

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  • Questions or Comments?

    1-844-425-9273

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  • SPL UNCLASSIFIED SECTION

    Distributed in the U.S. by Kimberly-Clark Global Sales, LLC, Roswell, GA 30076 USA

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  • PRINCIPAL DISPLAY PANEL - Kit Carton

    HALYARD*

    24-HOUR
    ORAL CARE KIT

    with BALLARD* Technology

    with
    H2O2

    q2

    1
    HALYARD*
    Prep
    Pack

    2
    HALYARD*
    Toothbrush
    Packs

    4
    HALYARD*
    Suction Swab
    Packs with H2O2

    6
    HALYARD*
    Suction Swab Packs
    with Alcohol-Free Mouthwash

    2
    HALYARD*
    Suction Catheter
    Packs

    Principal Display Panel - Kit Carton
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  • INGREDIENTS AND APPEARANCE
    Q2 ORAL CARE KIT  
    hydrogen peroxide kit
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:69697-983
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:69697-983-01 1 in 1 CARTON
    Quantity of Parts
    Part # Package Quantity Total Product Quantity
    Part 1 10 TUBE 100 g
    Part 2 4 CUP, UNIT-DOSE 56 mL
    Part 3 6 CUP, UNIT-DOSE 84 mL
    Part 1 of 3
    MOUTH MOISTURIZER 
    other oral hygiene products salve
    Product Information
    Route of Administration ORAL
    Other Ingredients
    Ingredient Kind Ingredient Name Quantity
    INGR Water (UNII: 059QF0KO0R)  
    INGR Xylitol (UNII: VCQ006KQ1E)  
    INGR Sodium Benzoate (UNII: OJ245FE5EU)  
    INGR Aloe Vera Flower (UNII: 575DY8C1ER)  
    INGR Propylene Glycol (UNII: 6DC9Q167V3)  
    INGR Potassium Sorbate (UNII: 1VPU26JZZ4)  
    INGR Sorbitol (UNII: 506T60A25R)  
    INGR Hydroxypropyl Cellulose (Type H) (UNII: RFW2ET671P)  
    INGR Dimethicone (UNII: 92RU3N3Y1O)  
    INGR Potassium Chloride (UNII: 660YQ98I10)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 10 g in 1 TUBE; Type 1: Convenience Kit of Co-Package
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    Cosmetic 06/25/2008
    Part 2 of 3
    HYDROGEN PEROXIDE 
    hydrogen peroxide mouthwash
    Product Information
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Hydrogen peroxide (UNII: BBX060AN9V) (Hydrogen peroxide - UNII:BBX060AN9V) Hydrogen peroxide 0.015 mg  in 1 mL
    Inactive Ingredients
    Ingredient Name Strength
    Water (UNII: 059QF0KO0R)  
    Glycerin (UNII: PDC6A3C0OX)  
    Mint (UNII: FV98Z8GITP)  
    Saccharin Sodium Dihydrate (UNII: SB8ZUX40TY)  
    Product Characteristics
    Color      Score     
    Shape Size
    Flavor MINT Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 14 mL in 1 CUP, UNIT-DOSE; Type 1: Convenience Kit of Co-Package
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC MONOGRAPH NOT FINAL part356 08/26/2008
    Part 3 of 3
    ALCOHOL FREE 
    mouthwashes and breath fresheners (liquids and sprays) mouthwash
    Product Information
    Route of Administration ORAL
    Other Ingredients
    Ingredient Kind Ingredient Name Quantity
    INGR Water (UNII: 059QF0KO0R)  
    INGR Benzoic Acid (UNII: 8SKN0B0MIM)  
    INGR Saccharin Sodium Dihydrate (UNII: SB8ZUX40TY)  
    INGR Sodium Benzoate (UNII: OJ245FE5EU)  
    INGR Glycerin (UNII: PDC6A3C0OX)  
    INGR Cetylpyridinium Chloride (UNII: D9OM4SK49P)  
    INGR D&C Green No. 5 (UNII: 8J6RDU8L9X)  
    INGR Sorbitol (UNII: 506T60A25R)  
    INGR Mint (UNII: FV98Z8GITP)  
    Product Characteristics
    Color      Score     
    Shape Size
    Flavor MINT Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 14 mL in 1 CUP, UNIT-DOSE ; Type 1: Convenience Kit of Co-Package
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    Cosmetic 03/13/2008
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part356 08/26/2008
    Labeler - Halyard Health (079617666)
    Establishment
    Name Address ID/FEI Business Operations
    Avent 049316284 MANUFACTURE(69697-983)
    Establishment
    Name Address ID/FEI Business Operations
    Elba 108428483 MANUFACTURE(69697-983)
    Establishment
    Name Address ID/FEI Business Operations
    Hi Tech Pharmacal 101196749 MANUFACTURE(69697-983)
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