FDA.reportPublic FDA data

ANTISEPTIC SINOFRESH KOOL BLAST THROAT

Manufacturer
EMS Contract Packaging
Effective date
2025-03-28
Label type
HUMAN OTC DRUG LABEL
Version
10
Source
legacy-cache
Hydrated at
2026-08-01 20:40:07

Label at a glance#

ProductANTISEPTIC SINOFRESH KOOL BLAST THROAT
Active ingredientMENTHA PIPERITA
Label structure10 sections

Indications and uses

KILLS GERMS AND BACTERIA REDUCES GERMS AND BACTERIA IN THE MOUTH AND THROAT

Dosage and administration

ADULTS AND CHILDREN 12 YEARS AND OLDER, 3 TO 4 SPRAYS IN THE THROAT, THREE TIMES A DAY, OR AS NEEDED CHILDREN UNDER 12 YEARS ASK A DOCTOR

Label contents#

Full prescribing information#

ACTIVE INGREDIENTS

OTC - ACTIVE INGREDIENT SECTION

MENTHA PIPERITA 3X

PURPOSE

OTC - PURPOSE SECTION

ORAL ANTISEPTIC

USES

INDICATIONS & USAGE SECTION

  • KILLS GERMS AND BACTERIA
  • REDUCES GERMS AND BACTERIA IN THE MOUTH AND THROAT

WARNINGS

WARNINGS SECTION

ASK A DOCTOR BEFORE USE IF YOU HAVE:

  • HAD ANY MEDICAL PROCEDURES FOR THE MOUTH OR THROAT
  • RAW, SCRATCHY, OR IRRITATED THROAT

wHEN USING THIS PRODUCT:

  • DO NOT SPRAY IN EYES. IF CONTACT OCCURS, RINSE WITH WATER
  • DO NOT SHARE DISPENSER WITH OTHERS

STOP USE AND ASK DOCTOR:

  • IF SYMPTOMS PERSIST FOR MORE THAN 7 DAYS OR WORSENS
  • A RASH OR IRRITATION OCCURS

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

KEEP OUT OF REACH OF CHILDREN.

IF MORE THAN IS USED FOR SPRAYING IS ACCIDENTALLY SWALLOWED, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER RIGHT AWAY, 800-222-1222

DIRECTIONS

DOSAGE & ADMINISTRATION SECTION

  • ADULTS AND CHILDREN 12 YEARS AND OLDER, 3 TO 4 SPRAYS IN THE THROAT, THREE TIMES A DAY, OR AS NEEDED
  • CHILDREN UNDER 12 YEARS ASK A DOCTOR

OTHER INFORMATION

OTHER SAFETY INFORMATION

STORE AT ROOM TEMPERATURE, AWAY FROM DIRECT SUNLIGHT

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

AQUA (WATER), BENZALKONIUM CHLORIDE, CETYLPYRIDINIUM CHLORIDE, EDETATE DISODIUM, EUCALYPTUS OIL, GLYCERIN, MENTHOL, POLYSORBATE 80, SORBITOL, SUCRALOSE, XYLITOL

QUESTIONS?

OTC - QUESTIONS SECTION

888-460-4774

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

01b LBL_Sinofresh Kool Blast_FR01b LBL_Sinofresh Kool Blast_FR

01b LBL_Sinofresh Kool Blast_BK01b LBL_Sinofresh Kool Blast_BK

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59228-105ANTISEPTIC SINOFRESH KOOL BLAST THROAT (MENTHA PIPERITA) SPRAY [EMS CONTRACT PACKAGING]10Legacy NDC20250331_5a788a54-edf7-410a-8db4-ffa5cec7ab36.zip

Products#

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

DailyMed product names page 1 of 1 · 13 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
59228-10559228-105-11

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
BENZALKONIUM CHLORIDEF5UM2KM3W7IACT
CETYLPYRIDINIUM CHLORIDED9OM4SK49PIACT
EDETATE SODIUMMP1J8420LUIACT
EUCALYPTUS OIL2R04ONI662IACT
GLYCERINPDC6A3C0OXIACT
MENTHOLL7T10EIP3AIACT
POLYSORBATE 806OZP39ZG8HIACT
SORBITOL506T60A25RIACT
SUCRALOSE96K6UQ3ZD4IACT
XYLITOLVCQ006KQ1EIACT
MENTHA PIPERITA79M2M2UDA9ACTIB

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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
46a1d671-1864-d030-e063-6294a90a115c5a788a54-edf7-410a-8db4-ffa5cec7ab362025-12-23WarningsExact identifier
spl set id: 5a788a54-edf7-410a-8db4-ffa5cec7ab36

Reported adverse events (FAERS/openFDA)#

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