FDA.reportPublic FDA data

CLBIO Dental clear

Manufacturer
Pharmacal-International. Co., Ltd.
Effective date
2023-02-02
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-01 21:38:15

Label at a glance#

ProductCLBIO Dental clear
Active ingredientSODIUM FLUORIDE
Label structure2 sections

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Sodium Fluoride (0.02%)

Purpose

OTC - PURPOSE SECTION

  • Anticavity mouthwash

Use

INDICATIONS & USAGE SECTION

  • Aids in prevention of dental cavities

Directions

DOSAGE & ADMINISTRATION SECTION

  • Rinse mouth with this CLIBIO Dental clear about 10~15ml for 30 seconds then expel

Average daily dose

  •  Use twice a day after brushing, meals, and before social occasions.

Warnings

WARNINGS SECTION

  • Keep out of reach of children.
  • Children under 7 years or younger must have parent supervision.
  • Do not swallow. In case of accidental ingestion, seek professional assistance or contact a Poison Control Center immediately.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Water,,Glycerin,Allantoin,Acetic acid,Xylitol,Sodium acetate,Sodium Benzoate,GreenTea Extract,Malic acid,L-Menthol,Propolis Extract,Citrus flavoring,Lemon flavoring,Sodium Saccharin,Lemon Oil,Cacao Color

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage description

image descriptionimage description

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
24765-128-012023-02-03C16284748780-1f386c64a-04e6-0266-e053-dadaa90a7c1aDrug Facts
24765-128-012023-01-30C16284748780-1f386c64a-04e6-0266-e053-dadaa90a7c1aDrug Facts

Products#

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

DailyMed product names page 1 of 1 · 15 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
24765-12824765-128-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 13 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
GLYCERINPDC6A3C0OXIACT
ALLANTOIN344S277G0ZIACT
ACETIC ACIDQ40Q9N063PIACT
XYLITOLVCQ006KQ1EIACT
SODIUM ACETATE4550K0SC9BIACT
SODIUM BENZOATEOJ245FE5EUIACT
GREEN TEA LEAFW2ZU1RY8B0IACT
MALIC ACID817L1N4CKPIACT
RACEMENTHOLYS08XHA860IACT
SACCHARIN SODIUM ANHYDROUSI4807BK602IACT
LEMON OILI9GRO824LLIACT
SODIUM FLUORIDE8ZYQ1474W7ACTIM

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
021e3f93-b37f-1a96-e063-6294a90ab9d67e55d8f2-659c-4922-83a7-beb5a1bd7add2023-08-04WarningsExact identifier
spl set id: 7e55d8f2-659c-4922-83a7-beb5a1bd7add

Reported adverse events (FAERS/openFDA)#

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