HYDROGEN PEROXIDE LIQUID KIMVENT ORAL CARE SUCTION SWAB PACK (HYDROGEN PEROXIDE) KIT [HALYARD HEALTH]

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HYDROGEN PEROXIDE LIQUID KIMVENT ORAL CARE SUCTION SWAB PACK (HYDROGEN PEROXIDE) KIT [HALYARD HEALTH]
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NDC 55118-990-01, 55118-993-01
Set ID c0996d60-7f1a-4143-8337-3fa64422e7dc
Category HUMAN OTC DRUG LABEL
Packager Halyard Health
Generic Name
Product Class
Product Number
Application Number PART356
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  • SPL UNCLASSIFIED SECTION

    Oral Debriding Agent

  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active Ingredient

    Hydrogen Peroxide 1.5%

  • Purpose

    Oral Debriding Agent

  • 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.
  • 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.

  • 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.
  • Other Information

    • Store at room temperature.
  • Inactive Ingredients

    Purified Water, Glycerin, Flavor, Sodium Saccharin

  • Questions or Comments?

    1-800-KCHELPS

  • PRINCIPAL DISPLAY PANEL - 44 ml Bottle Label

    Kimberly-Clark*

    KimVent*
    Hydrogen Peroxide
    Oral Rinse,
    Mint-Flavored

    44 ml (1.5 fl. oz.)

    Alcohol-Free

    Single Use Only

    REF 12263

    20-64-001-0-02

    LOT

    Use By

    PRINCIPAL DISPLAY PANEL - 44 ml Bottle Label
  • PRINCIPAL DISPLAY PANEL - Kit Carton

    Peel Here

    Kimberly-Clark*

    KimVent*
    Suction Swab
    Pack with H2O2

    Contains:

    • 1 Suction Swab
    • 1 Applicator Swab
    • 0.50 fl. oz. (14mL) of 1.5% H2O2 Oral Debriding Agent
    • 0.07 oz. (2g) Mouth Moisturizer
      Purified Water, Propylene Glycol, Sorbitol, Hydroxypropyl Methylcellulose, Dimethicone, Flavor,
      Xylitol, Aloe Vera Gel, Potassium Sorbate, Sodium Benzoate, Potassium Chloride, Sodium Chloride
    PRINCIPAL DISPLAY PANEL - Kit Carton
  • INGREDIENTS AND APPEARANCE
    HYDROGEN PEROXIDE 
    hydrogen peroxide liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55118-990
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Hydrogen Peroxide (UNII: BBX060AN9V) (Hydrogen Peroxide - UNII:BBX060AN9V) Hydrogen Peroxide0.015 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    Glycerin (UNII: PDC6A3C0OX)  
    Mint (UNII: FV98Z8GITP)  
    Saccharin Sodium (UNII: SB8ZUX40TY)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorMINTImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55118-990-0144 mL in 1 BOTTLE; Type 1: Convenience Kit of Co-Package
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart35608/26/2008
    KIMVENT ORAL CARE SUCTION SWAB PACK 
    hydrogen peroxide kit
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55118-993
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55118-993-011 in 1 CARTON
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 11 CUP 14 mL
    Part 21 TUBE 2 g
    Part 1 of 2
    HYDROGEN PEROXIDE 
    hydrogen peroxide liquid
    Product Information
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Hydrogen Peroxide (UNII: BBX060AN9V) (Hydrogen Peroxide - UNII:BBX060AN9V) Hydrogen Peroxide0.015 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    Glycerin (UNII: PDC6A3C0OX)  
    Mint (UNII: FV98Z8GITP)  
    Saccharin Sodium Dihydrate (UNII: SB8ZUX40TY)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorMINTImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    114 mL in 1 CUP; Type 1: Convenience Kit of Co-Package
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart35608/26/2008
    Part 2 of 2
    MOUTH MOISTURIZER 
    moisturizing salve
    Product Information
    Route of AdministrationORAL
    Other Ingredients
    Ingredient KindIngredient NameQuantity
    INGRSodium Benzoate (UNII: OJ245FE5EU)  
    INGRAloe Vera Flower (UNII: 575DY8C1ER)  
    INGRWater (UNII: 059QF0KO0R)  
    INGRXylitol (UNII: VCQ006KQ1E)  
    INGRPropylene Glycol (UNII: 6DC9Q167V3)  
    INGRPotassium Sorbate (UNII: 1VPU26JZZ4)  
    INGRSorbitol (UNII: 506T60A25R)  
    INGRHydroxypropyl Cellulose (Type H) (UNII: RFW2ET671P)  
    INGRDimethicone (UNII: 92RU3N3Y1O)  
    INGRPotassium Chloride (UNII: 660YQ98I10)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    12 g in 1 TUBE; Type 1: Convenience Kit of Co-Package
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    Cosmetic08/26/2008
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35608/26/2008
    Labeler - Halyard Health (079617666)
    Establishment
    NameAddressID/FEIBusiness Operations
    Avent049316284MANUFACTURE(55118-990, 55118-993) , RELABEL(55118-993) , REPACK(55118-993)
    Establishment
    NameAddressID/FEIBusiness Operations
    Elba Laboratories108428483MANUFACTURE(55118-990, 55118-993)
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