SUCTION TOOTHBRUSH WITH CORINZ ORAL RINSE- cetylpyridinium chloride kit

Suction Toothbrush with Corinz Oral Rinse by

Drug Labeling and Warnings

Suction Toothbrush with Corinz Oral Rinse by is a Otc medication manufactured, distributed, or labeled by Sage Products, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Use

Helps reduce chance of infection in minor oral irritation.

Drug Facts

• Active Ingredient: Purpose
• Cetylpyridinium chloride 0.05%: Antiseptic Rinse

INDICATIONS & USAGE

Warnings

Stop use and ask a doctor if:

• Sore mouth symptoms do not improve in 7 days.
• Swelling, rash or fever develops.
• Irritation, pain or redness persists or worsens.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children.

If more than used for antisepsis is accidentally swallowed, get medical help or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION

Directions

• Use up to 4 time daily or as directed by a dentist or doctor.
• Adults and children 3 years and older: rinse mouth with 1/2 Tbsp. for approx. one minute. Instruct to expectorate.
• Children under 3 years of age: consult a doctor.

Inactive Ingredients

Water, glycerin, xylitol, spearmint flavor, potassium sorbate, polysorbate 20, polysorbate 80m, hyrdroxyethylcellulose, citric acid, sodium saccharin, menthol.

Questions?

Call toll-free 800-323-2220

SPL UNCLASSIFIED SECTION

NOT MADE WITH NATURAL RUBBER LATEX 

MADE IN USA

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

SUCTION TOOTHBRUSH WITH CORINZ ORAL RINSE 
cetylpyridinium chloride kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 53462-561

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 53462-561-60	1 in 1 KIT; Type 1: Convenience Kit of Co-Package	01/24/2018

Quantity of Parts
Part #	Package Quantity	Total Product Quantity
Part 1	1 PACKET	7 mL
Part 2		1

Part 1 of 2

CORINZ 
cetylpyridinium chloride rinse

Product Information
Item Code (Source)	NDC: 53462-375
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P) (CETYLPYRIDINIUM - UNII:CUB7JI0JV3)	CETYLPYRIDINIUM CHLORIDE	0.5 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
XYLITOL (UNII: VCQ006KQ1E)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
HYDROXYETHYL CELLULOSE (4000 MPA.S AT 1%) (UNII: ZYD53NBL45)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1		1 in 1 KIT
1	NDC: 53462-375-60	7 mL in 1 PACKET; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part356	06/21/2000

Part 2 of 2

SODIUM BICARBONATE 
other oral hygiene products

Product Information

Other Ingredients
Ingredient Kind	Ingredient Name	Quantity
INGR	SODIUM BICARBONATE (UNII: 8MDF5V39QO)
INGR	CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)
INGR	SODIUM LAURYL SULFATE (UNII: 368GB5141J)
INGR	SODIUM BENZOATE (UNII: OJ245FE5EU)
INGR	WATER (UNII: 059QF0KO0R)
INGR	SACCHARIN SODIUM (UNII: SB8ZUX40TY)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Cosmetic

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part356	01/24/2018

Labeler - Sage Products, LLC (054326178)

Registrant - Sage Products, LLC (054326178)