TOOTHETTE ORAL CARE SINGLE USE SYSTEM WITH ANTISEPTIC ORAL RINSE- hydrogen peroxide 
Sage Products LLC

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.

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Toothette Oral Care Single Use System

Drug Facts

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

Uses

Warnings

Stop use and ask a doctor if:

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.

Directions

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.

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

* Manufactured for Sage Products LLC

Toothette Oral Care Single Use System with Antiseptic Oral Rinse

NDC 53462-120-60

6120 - Label
TOOTHETTE ORAL CARE SINGLE USE SYSTEM WITH ANTISEPTIC ORAL RINSE 
hydrogen peroxide kit
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53462-120
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:53462-120-601 in 1 KIT
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 11 POUCH 7 mL
Part 1 of 1
ANTISEPTIC ORAL RINSE 
cetylpyridinium chloride mouthwash
Product Information
Route of AdministrationBUCCAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P) (CETYLPYRIDINIUM - UNII:CUB7JI0JV3) CETYLPYRIDINIUM CHLORIDE.5 [iU]  in 1 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
11 in 1 PACKAGE
12 in 1 PACKET
17 mL in 1 POUCH
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35605/21/1998
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35603/31/2013
Labeler - Sage Products LLC (054326178)
Registrant - Sage Products LLC (054326178)
Establishment
NameAddressID/FEIBusiness Operations
Sage Products LLC054326178MANUFACTURE(53462-120)

Revised: 5/2014
Document Id: 816c614e-b914-ce70-3823-e8469e45dbd7
Set id: 816c614e-b914-ce70-3823-e8469e45dbd7
Version: 1
Effective Time: 20140519
 
Sage Products LLC