Label: ORAL CARE Q4 KIT- hydrogen peroxide kit

  • Category: HUMAN OTC DRUG LABEL

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 January 26, 2016

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

View All Sections
  • SPL UNCLASSIFIED SECTION

    Oral Debriding Agent

    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

  • SPL UNCLASSIFIED SECTION

     

  • SPL UNCLASSIFIED SECTION

    Antiplaque Solution

    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 accidently 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?

    1-844-425-9273

  • SPL UNCLASSIFIED SECTION

    Manufactured by Kimberly-Clark, Roswell, GA 30076 USA

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

  • PRINCIPAL DISPLAY PANEL - Kit Carton

    HALYARD*

    24-HOUR
    ORAL CARE KIT
    with BALLARD* Technology

    q4

    1
    HALYARD*
    Prep
    Pack

    2
    HALYARD*
    Toothbrush
    Packs

    4
    HALYARD*
    Suction Swab
    Packs with H2O2

    2
    HALYARD*
    Suction Catheter
    Packs

    Principal Display Panel - Kit Carton
  • INGREDIENTS AND APPEARANCE
    ORAL CARE Q4 KIT 
    hydrogen peroxide kit
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69697-986
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69697-986-011 in 1 CARTON
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 14 CUP, UNIT-DOSE 56 mL
    Part 22 CUP, UNIT-DOSE 28 mL
    Part 36 TUBE 60 g
    Part 1 of 3
    HYDROGEN PEROXIDE 
    hydrogen peroxide mouthwash
    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, UNIT-DOSE; 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 3
    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 Dihydrate (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 3 of 3
    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
    Cosmetic06/25/2008
    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(69697-986)
    Establishment
    NameAddressID/FEIBusiness Operations
    Elba108428483MANUFACTURE(69697-986)
    Establishment
    NameAddressID/FEIBusiness Operations
    Hi Tech Pharmacal101196749MANUFACTURE(69697-986)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials

More Info on this Drug

Get Label RSS Feed, View NDC Code(s)NEW!