DETOX DR. ORAL CLEAN CARE- allantoin, sodium fluoride liquid

Detox Dr. Oral Clean Care by

Drug Labeling and Warnings

Detox Dr. Oral Clean Care by is a Otc medication manufactured, distributed, or labeled by JANGIN PHARM CO.,LTD.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredient : Sodium fluoride

INACTIVE INGREDIENT

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.

PURPOSE

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.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children

INDICATIONS & USAGE

● 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

● 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

For dental use only

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

DETOX DR. ORAL CLEAN CARE 
allantoin, sodium fluoride liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69255-100
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	0.02 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
XYLITOL (UNII: VCQ006KQ1E)
ALLANTOIN (UNII: 344S277G0Z)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69255-100-01	250 mL in 1 BOTTLE; Type 0: Not a Combination Product	09/01/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part355	09/01/2018

Labeler - JANGIN PHARM CO.,LTD. (688733680)

Registrant - JANGIN PHARM CO.,LTD. (688733680)

Establishment
Name	Address	ID/FEI	Business Operations
JANGIN PHARM CO.,LTD.		688733680	manufacture(69255-100)