TOOTHETTE ORAL CARE SINGLE USE SYSTEM WITH ANTISEPTIC ORAL RINSE- hydrogen peroxide kit

Toothette Oral Care Single Use System with Antiseptic Oral Rinse by

Drug Labeling and Warnings

Toothette Oral Care Single Use System with Antiseptic Oral Rinse by is a Otc medication manufactured, distributed, or labeled by Sage Products LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

• Active ingredient: ANTISEPTIC ORAL RINSE*: Purpose
• Cetylpyridinium chloride .05%: Antiseptic Rinse

Uses

• Helps reduce the chance of infection in minor oral irritation.
• Aids in the removal of debris.

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

• Before opening, turn package over, burst solution packet with thumbs.
• Peel lid to open.
• Clean teeth and oral cavity for approximately one minute.
• Instruct to expectorate.
• Repeat cleaning with other swab as needed.
• Discard after use.

• Use up to 4 times daily or as directed by a dentist or doctor.
• Children under 12 years of age: supervise use.
• Children under 3 years of age: consult a dentist or doctor.
• Use a bite block when performing oral care on patients with altered levels of consciousness or those who cannot comprehend commands.
• Ensure foam is intact after use. If not, remove any particles from oral cavity.

Inactive ingredients*

Water, sorbitol, peppermint flavor, potassium sorbate, polysorbate 80, polysorbate 20, citric acid, FD&C Blue No. 1.

Questions?

Call toll-free 800-323-2220.

SPL UNCLASSIFIED SECTION

LATEX FREE FOR SINGLE USE ONLY MADE IN U.S.A.

* Manufactured for Sage Products LLC

PRINCIPAL DISPLAY PANEL

Toothette Oral Care Single Use System with Antiseptic Oral Rinse

NDC: 53462-120-60

INGREDIENTS AND APPEARANCE

TOOTHETTE ORAL CARE SINGLE USE SYSTEM WITH ANTISEPTIC ORAL RINSE 
hydrogen peroxide kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 53462-120

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 53462-120-60	1 in 1 KIT

Quantity of Parts
Part #	Package Quantity	Total Product Quantity
Part 1	1 POUCH	7 mL

Part 1 of 1

ANTISEPTIC ORAL RINSE 
cetylpyridinium chloride mouthwash

Product Information
Route of Administration	BUCCAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P) (CETYLPYRIDINIUM - UNII:CUB7JI0JV3)	CETYLPYRIDINIUM CHLORIDE	.5 [iU]  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
SORBITOL (UNII: 506T60A25R)
PEPPERMINT (UNII: V95R5KMY2B)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1		1 in 1 PACKAGE
1		2 in 1 PACKET
1		7 mL in 1 POUCH

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part356	05/21/1998

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part356	03/31/2013

Labeler - Sage Products LLC (054326178)

Registrant - Sage Products LLC (054326178)

Establishment
Name	Address	ID/FEI	Business Operations
Sage Products LLC		054326178	MANUFACTURE(53462-120)