Suction Toothbrushes

Manufacturer
Sage Products LLC
Effective date
2018-04-26
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 22:55:16

Label at a glance#

ProductSuction Toothbrushes
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, dental plaque and secretions.

Dosage and administration

Before opening , turn package over, burst solution packet with thumbs. Peel lid to open.  Remove toothbrush and attach to suction line.   Clean teeth and oral cavity for approximately one minute. To suction, place thumb over port. Repeat cleaning with other toothbrush 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 y...

Label contents#

Full prescribing information#

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

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

Uses

OTC - WHEN USING SECTION

  • Helps reduce the chance of infection in minor oral irritation.
  • Aids in the removal of debris, dental plaque 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 toothbrush and attach to suction line.  
  • Clean teeth and oral cavity for approximately one minute.
  • To suction, place thumb over port.
  • Repeat cleaning with other toothbrush 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

Suction Toothbrushes

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Suction Toothbrushes 6173Suction Toothbrushes 6173

Antispetic Oral Rinse

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Antiseptic Oral Rinse PacketAntiseptic Oral Rinse Packet

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1251617cetylpyridinium chloride 0.05 % MouthwashPSN3
1251617cetylpyridinium chloride 0.5 MG/ML MouthwashSCD3
1251617cetylpyridinium chloride 0.05 % MouthwashSY3

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
fb7ab793-2c12-4079-b100-a64f73bef25aProduct name420240712
b0cbf770-6cc3-4aa4-9158-755110c2b9f7Product name220230717
dc7c5daa-021f-40dd-b00d-63982cb2067aProduct name120230426
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name520200925
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name220160823
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
53462-273-602022-01-28C16284748780-1d6a99b39-8305-a426-e053-dadaa90af4c2Suction Toothbrushes

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53462-175-60Suction Toothbrushes7 mL in 1 PACKETMOUTHWASH7 mL0.5 mg in 1mL3
53462-273-60Suction Toothbrushes1 in 1 KITKIT13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53462-175SUCTION TOOTHBRUSHES (CETYLPYRIDINIUM CHLORIDE) KIT [SAGE PRODUCTS LLC]3Current NDC, Legacy NDC20180426_9f81731e-6343-49e0-a2b4-e8269d6bcd6a.zip
53462-273SUCTION TOOTHBRUSHES (CETYLPYRIDINIUM CHLORIDE) KIT [SAGE PRODUCTS LLC]3Legacy NDC, 2 package rows20180426_9f81731e-6343-49e0-a2b4-e8269d6bcd6a.zip

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
53462-27353462-273-60
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.

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
6ac2ea84-c4b2-8e59-e053-2a91aa0ac2c89f81731e-6343-49e0-a2b4-e8269d6bcd6a2018-04-26WarningsExact identifier
spl id: 6ac2ea84-c4b2-8e59-e053-2a91aa0ac2c8
spl set id: 9f81731e-6343-49e0-a2b4-e8269d6bcd6a

Reported adverse events (FAERS/openFDA)#

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