Label: HARING B DETOX MOUTHWASH- allantoin, sodium fluoride liquid
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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.
Updated January 10, 2019
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- ACTIVE INGREDIENT
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
- KEEP OUT OF REACH OF CHILDREN
- INDICATIONS & USAGE
● 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
- PRINCIPAL DISPLAY PANEL
INGREDIENTS AND APPEARANCE
HARING B DETOX MOUTHWASH
allantoin, sodium fluoride liquid
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69255-400 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) LEVOMENTHOL (UNII: BZ1R15MTK7) ALLANTOIN (UNII: 344S277G0Z) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69255-400-01 250 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(69255-400)