FDA.reportPublic FDA data

Dental Clear Natural

Manufacturer
Pharmacal-International. Co., Ltd.
Effective date
2011-12-01
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 22:30:24

Label at a glance#

ProductDental Clear Natural
Active ingredientSodium fluoride
Label structure2 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Sodium Fluoride (0.05%)

OTC - PURPOSE SECTION

Anticavity Rinse

WARNINGS SECTION

Keep out of reach of children.

Children under 7 years or younger must have parent supervision.

If one drank a lot of amount, drink some milk and please go see a doctor.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

INDICATIONS & USAGE SECTION

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

DOSAGE & ADMINISTRATION SECTION

Rinse mouth with this Dental Clear Natural about 10 -15 ml for 30 seconds and expel.

INACTIVE INGREDIENT SECTION

Water

L-Menthol

Glycerin

Acetic Acid

Sodium Acetate

Camellia Sinensis leaf Extract

Saccharin sodium

Sodium benzoate

Xylitol

Poloxamer

Citrus Medica Limonum Peel Oil

Malic Acid

Propolis Exxtract

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANELPACKAGE LABEL.PRINCIPAL DISPLAY PANEL

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
240698sodium fluoride 0.05 % (fluoride ion 0.02 % ) Oral RinsePSN2
240698sodium fluoride 0.5 MG/ML MouthwashSCD2
240698sodium fluoride 0.05 % (fluoride ion 0.02 % ) Oral RinseSY2

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
48747306-602a-42cc-957b-5b0c69158eeeProduct name120180604
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
db5ebcdb-b6ae-21cd-4dc5-76cd84b5578bProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
24765-100-012019-11-13C16284748780-197449f38-b624-f6ea-e053-dbdaa90aa703Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
24765-100-01Dental Clear Natural260 mL in 1 BOTTLE, PLASTICRINSE2602

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
24765-100DENTAL CLEAR NATURAL (SODIUM FLUORIDE) RINSE [PHARMACAL-INTERNATIONAL. CO., LTD.]2Legacy NDC, 1 package rows20111221_cc162a0e-b601-4466-9a4e-192985ee014a.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
Sodium fluorideACTIVE INGREDIENT8ZYQ1474W72
FLUORIDE IONACTIVE MOIETYQ80VPU408O2

Products#

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

DailyMed product names page 1 of 1 · 16 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
24765-10024765-100-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 14 matching rows.

Name, UNII, Kind table
NameUNIIKind
Sodium fluoride8ZYQ1474W7ACTIB
Water059QF0KO0RIACT
LEVOMENTHOLBZ1R15MTK7IACT
GLYCERINPDC6A3C0OXIACT
ACETIC ACIDQ40Q9N063PIACT
SODIUM ACETATE4550K0SC9BIACT
CAMELLIA SINENSIS ROOT8H54O0V2K3IACT
SACCHARIN SODIUM DIHYDRATESB8ZUX40TYIACT
SODIUM BENZOATEOJ245FE5EUIACT
XYLITOLVCQ006KQ1EIACT
POLOXAMER 1241S66E28KXAIACT
CITRUS LIMON FRUIT OIL0HNC1J1YEDIACT
MALIC ACID817L1N4CKPIACT
PROPOLIS WAX6Y8XYV2NOFIACT

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
edb22a90-fd3a-4510-aa55-af050daf0220cc162a0e-b601-4466-9a4e-192985ee014a2011-12-01WarningsExact identifier
spl id: edb22a90-fd3a-4510-aa55-af050daf0220
spl set id: cc162a0e-b601-4466-9a4e-192985ee014a

Reported adverse events (FAERS/openFDA)#

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