FDA.reportPublic FDA data

COOL SENSE

Manufacturer
Bncare Agriculture Co., Ltd.
Effective date
2020-03-19
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:04:02

Label at a glance#

ProductCOOL SENSE
Active ingredientPROPOLIS WAX
Label structure8 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Propolis extract (total flavonoid 5%)

OTC - PURPOSE SECTION

Can help the antimicrobial action in the mouth

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children

INDICATIONS & USAGE SECTION

3 times a day, spray 0.5ml (approx. 2 times) once orally

WARNINGS SECTION

  1. Those who are allergic to propolis should be careful about their intake, and those who have a specific or allergy should check their ingredients.
  2. If you experience any of the symptoms, please stop intake, consult a specialist or contact the customer service.
  3. Due to the nature of the raw materials, sediment may occur occasionally, but the quality is not abnormal.
  4. Check the expiration date before ingesting and follow the intake and intake method.
  5. Take care that the spray nozzle does not come in direct contact with your mouth and after spraying, clean and store the spray.

INACTIVE INGREDIENT SECTION

water, gamma-cyclodextrin, xylitol, anhydrous dextrose, glucosyl steviol, citric acid monohydrate, codonopsis pilosula whole (concentrate), pear (concentrate) juice, chitosan, turmeric, artificial flavor

DOSAGE & ADMINISTRATION SECTION

For dental use only

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

labellabel

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
73706-0001-22021-07-23C16284748780-1c7ccaba7-24a8-fd44-e053-dadaa90aa01ba1077d14-fe33-8683-e053-2995a90aa601
73706-0001-32021-07-23C16284748780-1c7ccaba7-24a8-fd44-e053-dadaa90aa01ba1077d14-fe33-8683-e053-2995a90aa601

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
73706-0001-1COOL SENSE10 mL in 1 BOTTLE, SPRAYLIQUID102
73706-0001-2COOL SENSE2 in 1 CARTONLIQUID22
73706-0001-3COOL SENSE2 in 1 BLISTER PACKLIQUID22

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
73706-0001COOL SENSE (PROPOLIS WAX) LIQUID [BNCARE AGRICULTURE CO., LTD.]2Legacy NDC, 3 package rows20200319_a1077d14-fe33-8683-e053-2995a90aa601.zip

Products#

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

DailyMed product names page 1 of 1 · 3 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
73706-000173706-0001-1, 73706-0001-2, 73706-0001-3

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 2 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
PROPOLIS WAX6Y8XYV2NOFACTIB

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
a1304497-df91-a20b-e053-2a95a90af2cca1077d14-fe33-8683-e053-2995a90aa6012020-03-19WarningsExact identifier
spl id: a1304497-df91-a20b-e053-2a95a90af2cc
spl set id: a1077d14-fe33-8683-e053-2995a90aa601

Reported adverse events (FAERS/openFDA)#

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