HARING B DETOX MOUTHWASH- allantoin, sodium fluoride liquid 
JANGIN PHARM CO.,LTD.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Active ingredient : Sodium fluoride

Preservative : Sodium Benzoate

Additives : Allantoin, Glycerin, Ethyl alcohol, Xylitol, Citric Acid Hydrate, Sodium Citrate Hydrate, Caramel Colorant, Glycyrrhiza Inflata Root Extract, Sophora Angustifolia Root Extract, Swertia Japonica Extract, camellia sinensis catechins, Red Ginseng Extract, Saccharin Sodium Hydrate, Polyoxyl 40 Hydrogenated Castor Oil, L-Menthol, Fragrance(Peach Flavor 7), DI-Water

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

● 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.

● 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.

For dental use only

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HARING B DETOX MOUTHWASH 
allantoin, sodium fluoride liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69255-400
Route of AdministrationDENTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION0.02 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
XYLITOL (UNII: VCQ006KQ1E)  
LEVOMENTHOL (UNII: BZ1R15MTK7)  
ALLANTOIN (UNII: 344S277G0Z)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69255-400-01250 mL in 1 BOTTLE; Type 0: Not a Combination Product09/01/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35509/01/2018
Labeler - JANGIN PHARM CO.,LTD. (688733680)
Registrant - JANGIN PHARM CO.,LTD. (688733680)
Establishment
NameAddressID/FEIBusiness Operations
JANGIN PHARM CO.,LTD.688733680manufacture(69255-400)

Revised: 1/2019
Document Id: 7f154579-1e92-5864-e053-2a91aa0aa76c
Set id: 7f154579-1e91-5864-e053-2a91aa0aa76c
Version: 1
Effective Time: 20190110
 
JANGIN PHARM CO.,LTD.