QCARE PETITE SIZE ORAL CLEANSING AND SUCTIONING SYSTEM- cetylpyridinium chloride 
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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QCare Petite Size Oral Cleansing and Suctioning System

Drug Facts

Suction Swab, Petite Size, with Antiseptic Oral Rinse/Suction Toothbrush, Petite Size, with Antiseptic Oral Rinse
Active Ingredient:
ANTISEPTIC ORAL RINSE:
Purpose
Cetylpyridinium chloride .05%Antiseptic Rinse

Uses

Suction Swab with Antiseptic Oral Rinse

Suction Toothbrush with Antiseptic Oral Rinse

Oropharyngeal Suction Catheter

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

Suction Swab with Antiseptic Oral Rinse

Suction Toothbrush with Antiseptic Oral Rinse

Oropharyngeal Suction Catheter

CAUTION:

Inactive Ingredients

Water, sorbitol, mentha piperita (peppermint) extract, potassium sorbate, polysorbate 80, polysorbate 20, citric acid, Blue 1 (CI 42090)

Questions?

Call toll-free 800-323-2220.

Mouth Moisturizer ingredients*

Water, cocos nucifera (coconut) oil, xylitol, flavor, cellulose gum, tocopheryl acetate (vitamin E), mentha veridis (spearmint) leaf oil, carbomer, polysorbate 20, polysorbate 80, potassium sorbate, cetylpyridinium chloride

* Manufactured for Sage Products LLC • Cary, IL

www.sageproducts.com/patents

NOT MADE WITH NATURAL RUBBER LATEX • FOR SINGLE USE ONLY • MADE IN USA

QCare Petite Size Oral Cleansing and Suctioning System

QCare 6714QCare 6714 filmQCare 6714 Drug Facts

Antiseptic Oral Rinse Solution

Antiseptic Oral Solution

QCARE PETITE SIZE ORAL CLEANSING AND SUCTIONING SYSTEM 
cetylpyridinium chloride kit
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53462-714
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:53462-714-601 in 1 KIT; Type 1: Convenience Kit of Co-Package04/02/2013
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 16 PACKET 42 mL  in 6 
Part 26 PACKET 12 g  in 6 
Part 1 of 2
ANTISEPTIC ORAL RINSE 
cetylpyridinium chloride mouthwash
Product Information
Item Code (Source)NDC:53462-175
Route of AdministrationBUCCAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P) (CETYLPYRIDINIUM - UNII:CUB7JI0JV3) CETYLPYRIDINIUM CHLORIDE0.5 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
SORBITOL (UNII: 506T60A25R)  
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
16 in 1 KIT
1NDC:53462-175-607 mL in 1 PACKET; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35605/21/1998
Part 2 of 2
MOUTH MOISTURIZER 
other oral hygiene products emulsion
Product Information
Route of AdministrationBUCCAL
Other Ingredients
Ingredient KindIngredient NameQuantity
INGRCOCONUT OIL (UNII: Q9L0O73W7L)  
INGRXYLITOL (UNII: VCQ006KQ1E)  
INGRCARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
INGR.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
INGRWATER (UNII: 059QF0KO0R)  
INGRCARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: HHT01ZNK31)  
INGRPOLYSORBATE 20 (UNII: 7T1F30V5YH)  
INGRPOLYSORBATE 80 (UNII: 6OZP39ZG8H)  
INGRPOTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
INGRCETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
16 in 1 KIT
12 g in 1 PACKET; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Cosmetic
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35604/02/2013
Labeler - Sage Products, LLC (054326178)

Revised: 1/2019
Document Id: 7fad186f-f7f7-6c35-e053-2a91aa0a873e
Set id: b08bc4f9-85db-b57c-5e1d-97e3383acf18
Version: 4
Effective Time: 20190117
 
Sage Products, LLC