Detox Dr. Oral Clean Care

Manufacturer
JANGIN PHARM CO.,LTD.
Effective date
2018-10-10
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:57:00

Label at a glance#

ProductDetox Dr. Oral Clean Care
Active ingredientSODIUM FLUORIDE
Label structure8 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active ingredient : Sodium fluoride

INACTIVE INGREDIENT SECTION

Preservative : Sodium Benzoate

Additives : Allantoin, L-Menthol, Glycyrrhiza Inflata Root Extract, Sophora Angustifolia Root Extract, Glycerin, camellia sinensis catechins, Saccharin Sodium Hydrate, Sodium Citrate Hydrate, Citric Acid Hydrate, Ethyl alcohol, Xylitol, DI-Water, Compound Perfume(apple flavor15), Caramel Colorant, Polyoxyl 40 Hydrogenated Castor Oil, Red Ginseng Extract.

OTC - PURPOSE SECTION

It keeps your teeth white, strong, and clean your mouth. It makes your mouth feel fresh, prevent cavities, and remove bad breath. Increase the aesthetic effect. Prevent gingivitis, periodontitis (pyorrhoea alveolaris), periodontal disease, and gum disease.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children

INDICATIONS & USAGE SECTION

● Administration and doses : Hold a suitable amount (10~15ml) in your mouth for about 30 seconds, then spit it out, and brush your teeth with a brush.

WARNINGS SECTION


● Caution : 1) The fluoride content of toothpaste is 90.5 ppm. 2) Take care not to swallow, and rinse your mouth thoroughly after use. 3) If gum or mouth damage is caused by using this toothpaste, stop using it and consult a doctor or dentist. 4) If used by children under the age of six years, use small amount of toothpaste about the size of peas at a time. Use under supervision of a guardian to avoid sucking or swallowing. 5) If a child under 6 years old swallows a large amount, consult a physician or dentist immediately. 6) Keep out of the reach of children under 6 years old. 7) This medicine contains sodium benzoate which can cause slight irritation to the skin, eyes and mucous membrane. 8) This product contains fluoride and ethanol and requires guidance from parents or adults when used by children. 9) This product contains ethanol(alcohol), so be careful when testing ethanol(alcohol) immediately after use as this product may affect the results of drinking measurement.

DOSAGE & ADMINISTRATION SECTION

For dental use only

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

11

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
69255-100-012021-01-29C16284748780-1ba0f9c33-4c58-a910-e053-dadaa90a0b8577dab129-738f-b787-e053-2a91aa0a2cdd

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69255-100-01Detox Dr. Oral Clean Care250 mL in 1 BOTTLELIQUID2501

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69255-100DETOX DR. ORAL CLEAN CARE (ALLANTOIN, SODIUM FLUORIDE) LIQUID [JANGIN PHARM CO.,LTD.]1Legacy NDC, 1 package rows20181012_77dab129-738f-b787-e053-2a91aa0a2cdd.zip

Products#

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

DailyMed product names page 1 of 1 · 6 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69255-10069255-100-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 3 matching rows.

Name, UNII, Kind table
NameUNIIKind
XYLITOLVCQ006KQ1EIACT
ALLANTOIN344S277G0ZIACT
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
77dab129-7390-b787-e053-2a91aa0a2cdd77dab129-738f-b787-e053-2a91aa0a2cdd2018-10-10WarningsExact identifier
spl id: 77dab129-7390-b787-e053-2a91aa0a2cdd
spl set id: 77dab129-738f-b787-e053-2a91aa0a2cdd

Reported adverse events (FAERS/openFDA)#

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