FDA.reportPublic FDA data

Suction Swab System

Manufacturer
Sage Products LLC
Effective date
2018-04-26
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-02 00:59:26

Label at a glance#

ProductSuction Swab System
Active ingredientCETYLPYRIDINIUM CHLORIDE
Label structure9 sections

Indications and uses

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

Dosage and administration

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 ...

Label contents#

Full prescribing information#

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

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

Uses

OTC - WHEN USING SECTION

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

Warnings

WARNINGS SECTION

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.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

OTC - PURPOSE SECTION

  • 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

INACTIVE INGREDIENT SECTION

Water, sorbitol, peppermint flavor, potssium sorbate, polysorbate 80, polysorbate 20, citric acid, FD&C Blue #1.

Questions

OTC - QUESTIONS SECTION

Call toll free 800-323-2220

SPL UNCLASSIFIED SECTION

MADE IN U.S.A.

NOT MADE WITH NATURAL RUBBER LATEX

Suction Swab System with Antiseptic Oral Rinse and Mouth Moisturizer

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Suction Swab System Reorder No. 6115

NDC: 53462-215-60

Suction Swab System 6115Suction Swab System 6115

Antiseptic Oral Rinse Packet

NDC: 53462-175-60

Antiseptic Oral RinseAntiseptic Oral Rinse

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 23 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
53462-21553462-215-60
53462-17553462-175-60

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 26 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
SORBITOL506T60A25RIACT
PEPPERMINTV95R5KMY2BIACT
POTASSIUM SORBATE1VPU26JZZ4IACT
POLYSORBATE 806OZP39ZG8HIACT
POLYSORBATE 207T1F30V5YHIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
FD&C BLUE NO. 1H3R47K3TBDIACT
CETYLPYRIDINIUM CHLORIDED9OM4SK49PACTIB
COCONUT OILQ9L0O73W7LINGR
XYLITOLVCQ006KQ1EINGR
CARBOXYMETHYLCELLULOSE SODIUMK679OBS311INGR
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0INGR
WATER059QF0KO0RINGR
POLYSORBATE 207T1F30V5YHINGR
POLYSORBATE 806OZP39ZG8HINGR
POTASSIUM SORBATE1VPU26JZZ4INGR
CETYLPYRIDINIUM CHLORIDED9OM4SK49PINGR
CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED)HHT01ZNK31INGR
SPEARMINT OILC3M81465G5INGR
SODIUM BICARBONATE8MDF5V39QOINGR
CARBOXYMETHYLCELLULOSE SODIUMK679OBS311INGR
SODIUM LAURYL SULFATE368GB5141JINGR
SODIUM BENZOATEOJ245FE5EUINGR
WATER059QF0KO0RINGR
SACCHARIN SODIUMSB8ZUX40TYINGR

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Antiseptic Oral RinseCETYLPYRIDINIUM CHLORIDESage Products LLCefff8bae-154d-46bc-8dd4-7168004256632026-06-24Exact identifier
ndc (package): 53462-175-60
ndc (product): 53462-175
ndc11 (package): 53462017560
c341b7d8-7a00-f815-e053-2995a90ac5a7695e1b66-4e07-4151-9085-4f2d9a5035992021-05-26WarningsExact identifier
spl set id: 695e1b66-4e07-4151-9085-4f2d9a503599

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.