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Q2 Oral Care Kit

Dosage form: kit
Ingredients: ; Hydrogen peroxide 0.015mg in 1mL
Labeler: Halyard Health
NDC Code: 69697-983

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.

Halyard
24-Hour Oral Care Kit

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?

1-844-425-9273

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

with
H2O2

q2

1
HALYARD*
Prep
Pack

2
HALYARD*
Toothbrush
Packs

4
HALYARD*
Suction Swab
Packs with H2O2

6
HALYARD*
Suction Swab Packs
with Alcohol-Free Mouthwash

2
HALYARD*
Suction Catheter
Packs

Established Pharmacological Class
SubstancePharmacological Class
Mouth MoisturizerOther Oral Hygiene Products
Alcohol freeMouthwashes and Breath Fresheners (liquids and sprays)
Q2 ORAL CARE KIT  
hydrogen peroxide kit
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69697-983
Packaging
#Item CodePackage Description
1NDC:69697-983-011 KIT in 1 CARTON
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 110 TUBE 100 g
Part 24 CUP, UNIT-DOSE 56 mL
Part 36 CUP, UNIT-DOSE 84 mL
Part 1 of 3
MOUTH MOISTURIZER 
mouth moisturizer salve
Product Information
Route of AdministrationORALDEA Schedule    
Ingredients
Ingredient NameQuantity
Water 
Xylitol 
Sodium Benzoate 
Aloe Vera Flower 
Propylene Glycol 
Potassium Sorbate 
Sorbitol 
Hydroxypropyl Cellulose (Type H) 
Dimethicone 
Potassium Chloride 
Packaging
#Item CodePackage Description
110 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Cosmetic06/25/2008
Part 2 of 3
HYDROGEN PEROXIDE 
hydrogen peroxide mouthwash
Product Information
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Hydrogen peroxide (Hydrogen peroxide) Hydrogen peroxide0.015 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
Water 
Glycerin 
Mint 
Saccharin Sodium Dihydrate 
Product Characteristics
Color    Score    
ShapeSize
FlavorMINTImprint Code
Contains    
Packaging
#Item CodePackage Description
114 mL in 1 CUP, UNIT-DOSE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart35608/26/2008
Part 3 of 3
ALCOHOL FREE 
alcohol free mouthwash
Product Information
Route of AdministrationORALDEA Schedule    
Ingredients
Ingredient NameQuantity
Water 
Benzoic Acid 
Saccharin Sodium Dihydrate 
Sodium Benzoate 
Glycerin 
Cetylpyridinium Chloride  
D&C Green No. 5 
Sorbitol 
Mint 
Product Characteristics
Color    Score    
ShapeSize
FlavorMINTImprint Code
Contains    
Packaging
#Item CodePackage Description
114 mL in 1 CUP, UNIT-DOSE
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 finalpart35608/26/2008
Labeler - Halyard Health (079617666)
Establishment
NameAddressID/FEIOperations
Avent049316284MANUFACTURE(69697-983)
Establishment
NameAddressID/FEIOperations
Elba108428483MANUFACTURE(69697-983)
Establishment
NameAddressID/FEIOperations
Hi Tech Pharmacal101196749MANUFACTURE(69697-983)

 
Halyard Health

Medically reviewed on Jan 25, 2018

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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