ORAL CARE Q4 KIT- hydrogen peroxide kit

Oral Care Q4 Kit by

Drug Labeling and Warnings

Oral Care Q4 Kit by is a Otc medication manufactured, distributed, or labeled by Halyard Health, Avent, Elba, Hi Tech Pharmacal. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

INGREDIENTS AND APPEARANCE

ORAL CARE Q4 KIT 
hydrogen peroxide kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69697-986

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69697-986-01	1 in 1 CARTON

Quantity of Parts
Part #	Package Quantity	Total Product Quantity
Part 1	4 CUP, UNIT-DOSE	56 mL
Part 2	2 CUP, UNIT-DOSE	28 mL
Part 3	6 TUBE	60 g

Part 1 of 3

HYDROGEN PEROXIDE 
hydrogen peroxide mouthwash

Product Information
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Hydrogen peroxide (UNII: BBX060AN9V) (Hydrogen peroxide - UNII:BBX060AN9V)	Hydrogen peroxide	0.015 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
Water (UNII: 059QF0KO0R)
Glycerin (UNII: PDC6A3C0OX)
Mint (UNII: FV98Z8GITP)
Saccharin Sodium Dihydrate (UNII: SB8ZUX40TY)

Product Characteristics
Color		Score
Shape		Size
Flavor	MINT	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1		14 mL in 1 CUP, UNIT-DOSE; Type 1: Convenience Kit of Co-Package

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part356	08/26/2008

Part 2 of 3

CETYLPYRIDINIUM CHLORIDE  
cetylpyridinium chloride mouthwash

Product Information
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Cetylpyridinium Chloride (UNII: D9OM4SK49P) (Cetylpyridinium - UNII:CUB7JI0JV3)	Cetylpyridinium Chloride	0.0005 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
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
Color	BLUE	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1		14 mL in 1 CUP, UNIT-DOSE ; Type 1: Convenience Kit of Co-Package

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part356	03/13/2008

Part 3 of 3

MOUTH MOISTURIZER 
other oral hygiene products salve

Product Information
Route of Administration	ORAL

Other Ingredients
Ingredient Kind	Ingredient Name	Quantity
INGR	Water (UNII: 059QF0KO0R)
INGR	Xylitol (UNII: VCQ006KQ1E)
INGR	Sodium Benzoate (UNII: OJ245FE5EU)
INGR	Aloe Vera Flower (UNII: 575DY8C1ER)
INGR	Propylene Glycol (UNII: 6DC9Q167V3)
INGR	Potassium Sorbate (UNII: 1VPU26JZZ4)
INGR	Sorbitol (UNII: 506T60A25R)
INGR	Hydroxypropyl Cellulose (Type H) (UNII: RFW2ET671P)
INGR	Dimethicone (UNII: 92RU3N3Y1O)
INGR	Potassium Chloride (UNII: 660YQ98I10)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1		10 g in 1 TUBE; Type 1: Convenience Kit of Co-Package

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Cosmetic		06/25/2008

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part356	03/13/2008

Labeler - Halyard Health (079617666)

Establishment
Name	Address	ID/FEI	Business Operations
Avent		049316284	MANUFACTURE(69697-986)

Establishment
Name	Address	ID/FEI	Business Operations
Elba		108428483	MANUFACTURE(69697-986)

Establishment
Name	Address	ID/FEI	Business Operations
Hi Tech Pharmacal		101196749	MANUFACTURE(69697-986)