FDA.reportPublic FDA data

Suction Swabs with Perox-A-Mint Solution

Manufacturer
Sage Products LLC
Effective date
2018-05-02
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
full-release
Hydrated at
2026-05-31 22:55:26

Label at a glance#

ProductSuction Swabs with Perox-A-Mint Solution
Active ingredientHYDROGEN PEROXIDE
Label structure8 sections

Indications and uses

Aids in the removal of debris and secretions.

Dosage and administration

Suction Swabs with Perox-A-Mint solution and Mouth Moisturizer Before opening , turn package over, burst solution packet with thumbs. Peel lid to open. Remove Suction Swab and attach to suction line. Clean teeth and oral cavity for approximately 1 minute. To suction, place thumb over port. Repeat cleaning with other Suction Swab as needed. To clear tubing, rinse with sterile saline or appropriate solution. Discard...

Label contents#

Full prescribing information#

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Suction Swab with Perox-A-Mint Solution
Active Ingredient: 
PEROX-A-MINT: 		Purpose
Hydrogen Peroxide 1.5%Oral Debriding Agent

Uses

OTC - WHEN USING SECTION

  • 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 debriding is accidentally swallowed, get medical help or contact a Poison Control Center right away.

Directions

OTC - PURPOSE SECTION

Suction Swabs with Perox-A-Mint solution and Mouth Moisturizer

  • Before opening, turn package over, burst solution packet with thumbs.
  • Peel lid to open.
  • Remove Suction Swab and attach to suction line.
  • Clean teeth and oral cavity for approximately 1 minute.
  • To suction, place thumb over port.
  • Repeat cleaning with other Suction Swab as needed.
  • To clear tubing, rinse with sterile saline or appropriate solution.
  • 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: 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.

Suction Swabs with Perox-A-Mint solution

  • Before opening, turn package over, burst solution packet with thumbs.
  • Peel lid to open.
  • Remove Suction Swab and attach to suction line.
  • Clean teeth and oral cavity for approximately 1 minute.
  • To suction, place thumb over port.
  • Repeat cleaning with other Suction Swab as needed.
  • To clear tubing, rinse with sterile saline or appropriate solution.
  • Discard after use.
  • 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).

OTC - QUESTIONS SECTION

Questions? Call toll-free 800-323-2220.

Suction Swabs with Perox-A-Mint Solution

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Suction Swab drug facts 6513Suction Swab drug facts 6513Suction Swab drug facts 6512Suction Swab drug facts 6512Perox-A-Mint SolutionPerox-A-Mint Solution

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
53462-813-602022-01-28C16284748780-1d6a99b39-3455-a426-e053-dadaa90af4c2Suction Swabs with Perox-A-Mint® Solution

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53462-813-60Suction Swabs with Perox-A-Mint Solution1 in 1 KITKIT16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53462-813SUCTION SWABS WITH PEROX-A-MINT SOLUTION (HYDROGEN PEROXIDE) KIT [SAGE PRODUCTS LLC]6Legacy NDC, 1 package rows20180503_de3aa385-0f73-49e5-8de5-027b10721f01.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
53462-81353462-813-60
53462-075

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
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
WATER059QF0KO0RIACT
POLYSORBATE 806OZP39ZG8HIACT
PHOSPHORIC ACIDE4GA8884NNIACT
SACCHARIN SODIUMSB8ZUX40TYIACT
FD&C BLUE NO. 1H3R47K3TBDIACT
FD&C YELLOW NO. 6H77VEI93A8IACT
HYDROGEN PEROXIDEBBX060AN9VACTIB

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 (product): 53462-075
6b3ec25a-65be-de80-e053-2991aa0aa70dde3aa385-0f73-49e5-8de5-027b10721f012018-05-02WarningsExact identifier
spl id: 6b3ec25a-65be-de80-e053-2991aa0aa70d
spl set id: de3aa385-0f73-49e5-8de5-027b10721f01

Reported adverse events (FAERS/openFDA)#

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