FDA.reportPublic FDA data

SinoFresh KoolBlast Oral Antiseptic Spray

Manufacturer
ZapVir Inc. | EMS Acquisition Corp
Effective date
2020-10-12
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 02:13:25

Label at a glance#

ProductSinoFresh KoolBlast
Active ingredientMENTHA PIPERITA
Label structure10 sections

Indications and uses

Oral Antiseptic • Reduces germs and bacteria in the mouth and throat

Dosage and administration

Directions • Adults and children 12 years of age 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
• Kills germs and bacteria
• Reduces germs and bacteria in the mouth and throat

Warnings

WARNINGS AND PRECAUTIONS SECTION

Warnings
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 eyes
with water
• do not share dispenser with others

Stop Use

OTC - STOP USE SECTION

Stop use and ask doctor if:
• condition persists for more than 7 days or worsens
• a rash or irritation occurs

Keep Our of Reach of Children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.
If more than used for spraying is accidentally swallowed,
get medical help or contact a Poison Control Center
right away, 800-222-1222

Dosage and Administration

DOSAGE & ADMINISTRATION SECTION

Directions
• Adults and children 12 years of age and older, 3 to 4
sprays in the throat, three times a day, or as needed
• Children under 12 years ask a doctor

Indications and Usage

INDICATIONS & USAGE SECTION

Oral Antiseptic

• Reduces germs and bacteria in the mouth and throat

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Inactive Ingredients: Aqua (water), benzalkonium chloride, cetylpyridinium chloride, edetate disodium, eucalyptus oil, glycerin,
menthol, polysorbate 80, sorbitol, sucralose, xylitol

Warnings

WARNINGS SECTION

Warnings
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 eyes
with water
• do not share dispenser with others
Stop use and ask doctor if:
• condition persists for more than 7 days or worsens
• a rash or irritation occurs

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Principal Display PanelPrincipal Display Panel

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
79961-003-012022-01-28C16284748780-1d6a99b39-62f5-a426-e053-dadaa90af4c2SinoFresh KoolBlast Oral Antiseptic Spray

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
79961-003-01SinoFresh KoolBlast60 g in 1 BOTTLE, SPRAYSPRAY601

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
79961-003SINOFRESH KOOLBLAST (SINOFRESH KOOLBLAST ORAL SPRAY) SPRAY [ZAPVIR INC.]1Legacy NDC, 1 package rows20201014_b17f470e-2eb0-b03a-e053-2995a90ad443.zip

Products#

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

DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
79961-00379961-003-01

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
SORBITOL506T60A25RIACT
EDETATE DISODIUM7FLD91C86KIACT
EUCALYPTUS OIL2R04ONI662IACT
MENTHOLL7T10EIP3AIACT
SUCRALOSE96K6UQ3ZD4IACT
GLYCERINPDC6A3C0OXIACT
POLYSORBATE 806OZP39ZG8HIACT
MENTHA PIPERITA79M2M2UDA9ACTIB
BENZALKONIUM CHLORIDEF5UM2KM3W7IACT
CETYLPYRIDINIUM CHLORIDED9OM4SK49PIACT
WATER059QF0KO0RIACT
XYLITOLVCQ006KQ1EIACT

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
b17f470e-2eb1-b03a-e053-2995a90ad443b17f470e-2eb0-b03a-e053-2995a90ad4432020-10-12WarningsExact identifier
spl id: b17f470e-2eb1-b03a-e053-2995a90ad443
spl set id: b17f470e-2eb0-b03a-e053-2995a90ad443

Reported adverse events (FAERS/openFDA)#

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