KIMVENT ORAL CARE TOOTHBRUSH PACK (CETYLPYRIDINIUM CHLORIDE) KIT [HALYARD HEALTH]

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KIMVENT ORAL CARE TOOTHBRUSH PACK (CETYLPYRIDINIUM CHLORIDE) KIT [HALYARD HEALTH]
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NDC 55118-980-01
Set ID a01f9845-70bd-4d9d-9498-9a18e6b77c82
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

  • Active Ingredient

    Cetylpyridinium Chloride 0.05

  • Purpose

    Antigingivitis/Antiplaque

  • Uses

    • Helps remove plaque that leads to gingivitis.
  • Warnings

    Stop use and ask a doctor if:

    • Gingivitis, bleeding, or redness persists for more than 2 weeks.
    • You have painful or swollen gums, pus from the gum line, loose teeth, or increasing spacing between the teeth. These may be signs or symptoms or periodontitis, a serious form of gum disease.

    Keep out of reach of children under 6 years of age.

    If more than used for rinsing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    • Adults and children 12 years of age and older: Use as directed by a dentist. Do not swallow the rinse.
    • Children 6 years to under 12 years of age: supervised use.
    • Children under 6 years of age: do not use.
    • Use only under health care practitioner's supervision.
  • Other Information

    • This rinse is not intended to replace brushing or flossing.
    • Store at room temperature.
  • Inactive Ingredients

    Purified Water, Glycerin, Sorbitol, Flavor, Benzoic Acid, Sodium Benzoate, Sodium Saccharin, D&C Green 5

  • Questions or Comments?

    1-800-KCHELPS

  • SPL UNCLASSIFIED SECTION

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

  • PRINCIPAL DISPLAY PANEL - Kit Carton

    Peel Here

    Kimberly-Clark*

    KimVent*
    Toothbrush
    Pack with Antiplaque
    Solution

    Contains:

    • 1 Suction Toothbrush
    • 1 Applicator Swab
    • 0.5 fl. oz. (14mL) of 0.05% Antiplaque Solution
    • 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
    KIMVENT ORAL CARE TOOTHBRUSH PACK 
    cetylpyridinium chloride kit
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55118-980
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55118-980-011 in 1 CARTON
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 11 CUP, UNIT-DOSE 14 mL
    Part 21 TUBE 10 g
    Part 1 of 2
    CETYLPYRIDINIUM CHLORIDE 
    cetylpyridinium chloride mouthwash
    Product Information
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Cetylpyridinium Chloride (UNII: D9OM4SK49P) (Cetylpyridinium - UNII:CUB7JI0JV3) Cetylpyridinium Chloride0.0005 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    Benzoic Acid (UNII: 8SKN0B0MIM)  
    Saccharin Sodium (UNII: SB8ZUX40TY)  
    Sodium Benzoate (UNII: OJ245FE5EU)  
    Glycerin (UNII: PDC6A3C0OX)  
    D&C Green No. 5 (UNII: 8J6RDU8L9X)  
    Sorbitol (UNII: 506T60A25R)  
    Mint (UNII: FV98Z8GITP)  
    Product Characteristics
    ColorBLUEScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    114 mL in 1 CUP, UNIT-DOSE; Type 1: Convenience Kit of Co-Package
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart35603/13/2008
    Part 2 of 2
    MOUTH MOISTURIZER 
    other oral hygiene products salve
    Product Information
    Route of AdministrationORAL
    Other Ingredients
    Ingredient KindIngredient NameQuantity
    INGRWater (UNII: 059QF0KO0R)  
    INGRXylitol (UNII: VCQ006KQ1E)  
    INGRSodium Benzoate (UNII: OJ245FE5EU)  
    INGRAloe Vera Flower (UNII: 575DY8C1ER)  
    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
    110 g in 1 TUBE; Type 1: Convenience Kit of Co-Package
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    Cosmetic03/13/2008
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35603/13/2008
    Labeler - Halyard Health (079617666)
    Establishment
    NameAddressID/FEIBusiness Operations
    Avent049316284MANUFACTURE(55118-980) , RELABEL(55118-980) , REPACK(55118-980)
    Establishment
    NameAddressID/FEIBusiness Operations
    Elba108428483MANUFACTURE(55118-980)
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