KIMVENT ORAL CARE TOOTHBRUSH PACK- cetylpyridinium chloride kit

Kimvent Oral Care Toothbrush pack by

Drug Labeling and Warnings

Kimvent Oral Care Toothbrush pack by is a Otc medication manufactured, distributed, or labeled by Halyard Health, Avent, Elba. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

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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

INGREDIENTS AND APPEARANCE

KIMVENT ORAL CARE TOOTHBRUSH PACK 
cetylpyridinium chloride kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55118-980

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 55118-980-01	1 in 1 CARTON

Quantity of Parts
Part #	Package Quantity	Total Product Quantity
Part 1	1 CUP, UNIT-DOSE	14 mL
Part 2	1 TUBE	10 g

Part 1 of 2

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 (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 2 of 2

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		03/13/2008

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(55118-980) , RELABEL(55118-980) , REPACK(55118-980)

Establishment
Name	Address	ID/FEI	Business Operations
Elba		108428483	MANUFACTURE(55118-980)