ORAL CARE Q4 KIT- hydrogen peroxide 
Halyard Health

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.

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Halyard
24-Hour Oral Care Kit

Oral Debriding Agent

Drug Facts

Active Ingredient

Hydrogen Peroxide 1.5%

Purpose

Oral Debriding Agent

Uses

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

Other Information

Inactive Ingredients

Purified Water, Glycerin, Flavor, Sodium Saccharin

Questions or Comments?

1-800-KCHELPS

 

Antiplaque Solution

Drug Facts

Active Ingredient

Cetylpyridinium Chloride 0.05%

Purpose

Antigingivitis/Antiplaque

Uses

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

Other Information

Inactive Ingredients

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

Questions or Comments?

1-844-425-9273

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
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)

Revised: 1/2016
Document Id: 4ea2da50-ef91-4105-b068-d94dfed088a9
Set id: 10c813e1-87a8-408a-a190-7e5f82bd9306
Version: 1
Effective Time: 20160126
 
Halyard Health