Label: KIMVENT ORAL CARE TOOTHBRUSH PACK- cetylpyridinium chloride kit

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated March 23, 2015

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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:69697-980
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69697-980-011 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(69697-980) , RELABEL(69697-980) , REPACK(69697-980)
    Establishment
    NameAddressID/FEIBusiness Operations
    Elba108428483MANUFACTURE(69697-980)
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