FDA.reportPublic FDA data

Suction Toothbrush with Perox-A-Mint Solution

Manufacturer
Sage Products, LLC
Effective date
2019-09-20
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
full-release
Hydrated at
2026-05-31 23:00:33

Label at a glance#

ProductSuction Toothbrush with Perox-A-Mint Solution
Active ingredientHYDROGEN PEROXIDE
Label structure9 sections

Indications and uses

Aids in the removal of dental plaque, debris and secretions.

Dosage and administration

Suction Toothbrush with Perox-A-Mint Solution and Mouth Moisturizer 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 1 minute. To suction, place thumb over port. To clear tubing, rinse with sterile saline or appropriate solution. Discard after use. Use Applicator Swab to apply Mouth Mo...

Label contents#

Full prescribing information#

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

 Active Ingredients Purpose

 Perox-A-Mint Solution

 Hydrogen peroxide 1.5% Oral Debriding Agent

Uses

OTC - WHEN USING SECTION

  • Aids in the removal of dental plaque, 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 debriding is accidentally swallowed, get medical help or contact a Poison Control Center right away.

Directions

OTC - PURPOSE SECTION

Suction Toothbrush with Perox-A-Mint Solution and Mouth Moisturizer

  • 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 1 minute.
  • To suction, place thumb over port.
  • To clear tubing, rinse with sterile saline or appropriate solution.
  • Discard after use.
  • Use Applicator Swab to 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: supervise use.
  • 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, menthol flavor, polysorbate 80, phosphoric acid, sodium saccharin, Blue 1 (CI 42090), Yellow 6 (CI 15985)

Questions

OTC - QUESTIONS SECTION

Call toll-free 800-323-2220

Suction Toothbrush with Perox-A-Mint

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Single Use System 6572Single Use System 6572

Perox-A-Mint

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Perox-A-MintPerox-A-Mint

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
358975hydrogen peroxide 1.5 % MouthwashPSN6
1866540Perox-A-Mint 1.5 % MouthwashPSN6
1866540hydrogen peroxide 15 MG/ML Mouthwash [Perox-A-Mint]SBD6
358975hydrogen peroxide 15 MG/ML MouthwashSCD6
358975hydrogen peroxide 1.5 % MouthwashSY6
1866540Perox-A-Mint 1.5 % MouthwashSY6
1866540Perox-A-Mint 15 MG/ML MouthwashSY6

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
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
3c386306-c48a-413e-bb69-70cb268496f3Product name120210727
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name520200925
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
5eb9f24b-9328-475e-af0a-18021935eb6aProduct name120180220
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
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
53462-572-602021-01-29C16284748780-1ba0f9c33-13b9-a910-e053-dadaa90a0b85Suction Toothbrush with Perox-A-Mint Solution

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53462-075-60Suction Toothbrush with Perox-A-Mint Solution7 mL in 1 PACKETMOUTHWASH7 mL15 mg in 1mL6
53462-572-60Suction Toothbrush with Perox-A-Mint Solution1 in 1 KITKIT16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53462-075SUCTION TOOTHBRUSH WITH PEROX-A-MINT SOLUTION (HYDROGEN PEROXIDE) KIT [SAGE PRODUCTS, LLC]6Current NDC, Legacy NDC20190920_014175de-0f9f-47f0-a04e-02d66ada1cdd.zip
53462-572SUCTION TOOTHBRUSH WITH PEROX-A-MINT SOLUTION (HYDROGEN PEROXIDE) KIT [SAGE PRODUCTS, LLC]6Legacy NDC, 2 package rows20190920_014175de-0f9f-47f0-a04e-02d66ada1cdd.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
53462-075-30ML - Milliliter53462-075beb020b4-a3b3-402a-afb9-4fd8e44bcf6f12013-11-04
53462-075-40ML - Milliliter53462-075dfa841fb-924e-4efb-bc49-688eeb1c471c12013-11-04

Products#

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

DailyMed product names page 1 of 1 · 22 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
53462-57253462-572-60
53462-07553462-075-60

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 24 matching rows.

Name, UNII, Kind table
NameUNIIKind
SODIUM BICARBONATE8MDF5V39QOINGR
CARBOXYMETHYLCELLULOSE SODIUMK679OBS311INGR
SODIUM LAURYL SULFATE368GB5141JINGR
SODIUM BENZOATEOJ245FE5EUINGR
WATER059QF0KO0RINGR
SACCHARIN SODIUMSB8ZUX40TYINGR
WATER059QF0KO0RIACT
POLYSORBATE 806OZP39ZG8HIACT
PHOSPHORIC ACIDE4GA8884NNIACT
SACCHARIN SODIUMSB8ZUX40TYIACT
FD&C BLUE NO. 1H3R47K3TBDIACT
FD&C YELLOW NO. 6H77VEI93A8IACT
HYDROGEN PEROXIDEBBX060AN9VACTIB
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

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
Perox-A-Mint SolutionHYDROGEN PEROXIDESage Products, LLC50823ff5-ad08-4449-bc4a-9a8ae25ec0d52026-06-24WarningsExact identifier
ndc (package): 53462-075-60
ndc (product): 53462-075
ndc11 (package): 53462007560
92fcb4b0-2162-4475-e053-2995a90ae959014175de-0f9f-47f0-a04e-02d66ada1cdd2019-09-20WarningsExact identifier
spl id: 92fcb4b0-2162-4475-e053-2995a90ae959
spl set id: 014175de-0f9f-47f0-a04e-02d66ada1cdd

Reported adverse events (FAERS/openFDA)#

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