QCARE ORAL CLEANSING AND SUCTIONING SYSTEM, Q4- cetylpyridinium chloride and 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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QCare Oral Cleansing and Suctioning System, Q4

Drug Facts

Suction Swab with Perox-A-Mint® Solution 
Active Ingredient Purpose
 PEROX-A-MINT
 Hydrogen peroxide 1.5% Oral debriding agent

Use

Warnings

Stop use and ask a doctor if:

Keep out of the reach of children.
If more than used for debriding is accidentally swallowed, get medical help or contact a Poison Control Center right away.

Directions

Inactive ingredients

Water, menthol flavor, polysorbate 80, phosphoric acid, sodium saccharin, Blue 1 (CI 42090), Yellow 6 (CI 15985)

Drug Facts

 Suction Toothbrush with Antiplaque Solution
Active Ingredient Purpose
 ANTIPLAQUE
 Cetylpyridinium chloride .05% Antigingivitis/antiplaque

Uses

Suction Toothbrush with Antiplaque Solution:

Oropharyneal Suction Catheter packages:

Warnings

Stop use and ask a dentist if:

Keep out of the reach of children under 6 years of age.
If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

Directions

Suction Toothbrush with Antiplaque Solution:

Oropharyngeal Suction Catheter:

Caution

Inactive Ingredients

Suction Toothbrush with Antiplaque Solution:

Water, sorbitol, peppermint flavor, potassium sorbate, polysorbate 80, polysorbate 20, citric acid, Blue 1 (CI42090).

Questions?

Call toll-free 800–323–2220

Manufactured for Sage Products, LLC Cary, IL

NOT MADE WITH NATURAL RUBBER LATEX. FOR SINGLE USE ONLY. MADE IN U.S.A.

QCare Oral Cleansing & Suctioning System, q4 Reorder#6424

Perox-A-Mint SolutionAntiplaque SolutionQCare 6424QCare 6424 FilmQCare 6424 Drug Facts

QCARE ORAL CLEANSING AND SUCTIONING SYSTEM, Q4 
cetylpyridinium chloride and hydrogen peroxide kit
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53462-424
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:53462-424-601 in 1 KIT; Type 1: Convenience Kit of Co-Package06/30/2008
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 14 PACKET 28 mL
Part 22 PACKET 14 mL
Part 36 PACKET 12 g
Part 4
Part 1 of 4
PEROX-A-MINT SOLUTION 
hydrogen peroxide mouthwash
Product Information
Item Code (Source)NDC:53462-075
Route of AdministrationBUCCAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HYDROGEN PEROXIDE (UNII: BBX060AN9V) (HYDROGEN PEROXIDE - UNII:BBX060AN9V) HYDROGEN PEROXIDE15 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
PHOSPHORIC ACID (UNII: E4GA8884NN)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
14 in 1 KIT
1NDC:53462-075-607 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 4
ANTIPLAQUE SOLUTION 
cetylpyridinium chloride mouthwash
Product Information
Item Code (Source)NDC:53462-275
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
WATER (UNII: 059QF0KO0R)  
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)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
12 in 1 KIT
1NDC:53462-275-607 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 finalpart35601/09/2009
Part 3 of 4
MOUTH MOISTURIZER 
other oral hygiene products
Product Information
Other Ingredients
Ingredient KindIngredient NameQuantity
INGRCOCONUT OIL (UNII: Q9L0O73W7L)  
INGRXYLITOL (UNII: VCQ006KQ1E)  
INGRCARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
INGR.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
INGRSPEARMINT OIL (UNII: C3M81465G5)  
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
Part 4 of 4
SODIUM BICARBONATE 
other oral hygiene products
Product Information
Other Ingredients
Ingredient KindIngredient NameQuantity
INGRSODIUM BICARBONATE (UNII: 8MDF5V39QO)  
INGRCARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
INGRSODIUM LAURYL SULFATE (UNII: 368GB5141J)  
INGRSODIUM BENZOATE (UNII: OJ245FE5EU)  
INGRWATER (UNII: 059QF0KO0R)  
INGRSACCHARIN SODIUM (UNII: SB8ZUX40TY)  
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 finalpart35606/30/2008
Labeler - Sage Products, LLC (054326178)

Revised: 6/2018
Document Id: 6fcad18d-eecd-2278-e053-2991aa0a8024
Set id: 567bf599-4958-91c7-5c01-9c38a0d2da52
Version: 7
Effective Time: 20180629
 
Sage Products, LLC