SUCTION SWAB 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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Suction Swab System

Drug Facts

 Active Ingredient Purpose
Antiseptic Oral Rinse
Cetylpyridinium chloride .05%Oral Antiseptic

Uses

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

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.

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

Directions

  • Before opening, turn package over, burst solution packet with thumbs.
  • Peel lid to open. 
  • Remove swab and attach to suction line.  
  • Clean teeth and oral cavity for approximately one minute.
  • To suction, place thumb over port.
  • Repeat cleaning with other swab as needed.
  • Discard after use.
  • Apply Mouth Moisturizer as needed.
  • Use up to 4 times daily, or as directed by a dentist or doctor.
  • Children under 12 years of age should be supervised in the use of this product.
  • 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, potssium sorbate, polysorbate 80, polysorbate 20, citric acid, FD&C Blue #1.

Questions

Call toll free 800-323-2220

MADE IN U.S.A.

NOT MADE WITH NATURAL RUBBER LATEX

Suction Swab System with Antiseptic Oral Rinse and Mouth Moisturizer

Suction Swab System Reorder No. 6115

NDC: 53462-215-60

Suction Swab System 6115

Antiseptic Oral Rinse Packet

NDC: 53462-175-60

Antiseptic Oral Rinse

SUCTION SWAB SYSTEM 
cetylpyridinium chloride kit
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53462-215
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:53462-215-601 in 1 KIT; Type 1: Convenience Kit of Co-Package12/30/2006
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 11 PACKET 7 mL
Part 21 PACKET 2 g
Part 3 1 
Part 1 of 3
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
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
11 in 1 KIT
1NDC:53462-175-307 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 finalpart35606/21/2000
Part 2 of 3
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)  
INGRWATER (UNII: 059QF0KO0R)  
INGRPOLYSORBATE 20 (UNII: 7T1F30V5YH)  
INGRPOLYSORBATE 80 (UNII: 6OZP39ZG8H)  
INGRPOTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
INGRCETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P)  
INGRCARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: HHT01ZNK31)  
INGRSPEARMINT OIL (UNII: C3M81465G5)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
11 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 3 of 3
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 finalpart35612/30/200605/26/2021
Labeler - Sage Products LLC (054326178)
Registrant - Sage Products LLC (054326178)

Revised: 5/2021
Document Id: c341b7d8-7a00-f815-e053-2995a90ac5a7
Set id: 695e1b66-4e07-4151-9085-4f2d9a503599
Version: 4
Effective Time: 20210526
 
Sage Products LLC