FDA.reportPublic FDA data

Suction Swab System with Perox-A-Mint Solution - Suction Swab

Manufacturer
Sage Products LLC
Effective date
2019-01-17
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-05-31 22:58:14

Label at a glance#

ProductSuction Swab System with Perox-A-Mint Solution - Suction Swab and Suction Toothbrush
Active ingredientHYDROGEN PEROXIDE
Label structure9 sections

Indications and uses

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

Dosage and administration

Suction Swab Use as directed on individual packages Apply Mouth Moisturizer as needed. Discard after use. Suction Swabs and Applicator Swabs are intended for single oral use only. 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...

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

Suction Swab

  • Aids in the removal of debris and secretions.

Suction Swab and Suction Toothbrush

  • 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 Swab

  • Use as directed on individual packages
  • Apply Mouth Moisturizer as needed.
  • Discard after use.
  • Suction Swabs and Applicator Swabs are intended for single oral use only.
  • 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 Swab and Suction Toothbrush

  • Use as directed on individual packages
  • Apply Mouth Moisturizer as needed.
  • Discard after use.
  • Suction Toothbrushes, Suction Swabs and Applicator Swabs are intended for single oral use only.
  • 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 Swab System with Perox-A-Mint Solution - Suction Swab

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Suction Swab System 6550Suction Swab System 6550Suction Swab 6512Suction Swab 6512

Suction Swab System with Perox-A-Mint Solution - Suction Swab and Suction Toothbrush

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Suction Swab System 6552Suction Swab System 6552Suction Toothbrush 6571Suction Toothbrush 6571

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
358975hydrogen peroxide 1.5 % MouthwashPSN4
1866540Perox-A-Mint 1.5 % MouthwashPSN4
1866540hydrogen peroxide 15 MG/ML Mouthwash [Perox-A-Mint]SBD4
358975hydrogen peroxide 15 MG/ML MouthwashSCD4
358975hydrogen peroxide 1.5 % MouthwashSY4
1866540Perox-A-Mint 1.5 % MouthwashSY4
1866540Perox-A-Mint 15 MG/ML MouthwashSY4

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
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
53462-553-602021-01-29C16284748780-1ba0f9c33-386d-a910-e053-dadaa90a0b85Suction Swab System with Perox-A-Mint® Solution
53462-650-602021-01-29C16284748780-1ba0f9c33-386d-a910-e053-dadaa90a0b85Suction Swab System with Perox-A-Mint® Solution

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53462-553-60Suction Swab System with Perox-A-Mint Solution - Suction Swab and Suction Toothbrush1 in 1 KITKIT14
53462-650-60Suction Swab System with Perox-A-Mint Solution - Suction Swab1 in 1 KITKIT14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53462-553SUCTION SWAB SYSTEM WITH PEROX-A-MINT SOLUTION - SUCTION SWAB AND SUCTION TOOTHBRUSH (HYDROGEN PEROXIDE) KIT SUCTION SWAB SYSTEM WITH PEROX-A-MINT SOLUTION - SUCTION SWAB (HYDROGEN PEROXIDE) KIT [SAGE PRODUCTS LLC]4Legacy NDC, 1 package rows20190118_168d67dc-419f-489d-a64b-db3fc54ae0c9.zip
53462-650SUCTION SWAB SYSTEM WITH PEROX-A-MINT SOLUTION - SUCTION SWAB AND SUCTION TOOTHBRUSH (HYDROGEN PEROXIDE) KIT SUCTION SWAB SYSTEM WITH PEROX-A-MINT SOLUTION - SUCTION SWAB (HYDROGEN PEROXIDE) KIT [SAGE PRODUCTS LLC]4Legacy NDC, 1 package rows20190118_168d67dc-419f-489d-a64b-db3fc54ae0c9.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 · 23 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
53462-55353462-553-60
53462-075
53462-65053462-650-60

Ingredients#

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

DailyMed ingredient rows page 1 of 2 · 48 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
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

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
7fae87d8-2d35-97d3-e053-2a91aa0a4a82168d67dc-419f-489d-a64b-db3fc54ae0c92019-01-17WarningsExact identifier
spl id: 7fae87d8-2d35-97d3-e053-2a91aa0a4a82
spl set id: 168d67dc-419f-489d-a64b-db3fc54ae0c9

Reported adverse events (FAERS/openFDA)#

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