Label: TOOTHY ORAL SOLUTION- toothy oral expert liquid
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Contains inactivated NDC Code(s)
NDC Code(s): 54465-001-01 - Packager: Shenzhen Roselle Bio-Technology Holding Co.,Ltd.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved drug other
DISCLAIMER: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.
Drug Label Information
Updated April 15, 2020
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- DOSAGE & ADMINISTRATION
- INACTIVE INGREDIENT
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INDICATIONS & USAGE
For external use only. Open the dust cover, tilt your head slightly backwards, rotate the nozzle to the front of the mouth,tap the manual pump, and spray the antibacterial solution into mouth. The recommended dosage is 4 sprays per use (3-4 times per day), however this product can be used more times per day depending on specific situations. Clean the nozzle and put the dust cover back on after each use.
- ACTIVE INGREDIENT
- KEEP OUT OF REACH OF CHILDREN
- PURPOSE
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WARNINGS
1.This product is a hygiene product not intended to replace a doctor' S recommended medical treatment.
2.The contents of this product are all natural, when spraying in the mouth, swallowing a small amount of liquid is fine. Please consult a
medical professional if there is any discomfort or negative reaction.
3. Do not eat or drink anything for at least 20 minutes after using this product. It is recommended to avoid eating spicy food while using this product as a treatment.
4. Please keep this product out of the reach of children.
5. Do not use this product if you are allergic to it.
6. Please store this product in a dry place at room temperature. - PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
TOOTHY ORAL SOLUTION
toothy oral expert liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:54465-001 Route of Administration EXTRACORPOREAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SOPHORA FLAVESCENS WHOLE (UNII: X8KX602M5L) (SOPHORA FLAVESCENS WHOLE - UNII:X8KX602M5L) SOPHORA FLAVESCENS WHOLE 135 g in 15 L HOUTTUYNIA CORDATA WHOLE (UNII: O3E12ZLW5T) (HOUTTUYNIA CORDATA WHOLE - UNII:O3E12ZLW5T) HOUTTUYNIA CORDATA WHOLE 135 g in 15 L Inactive Ingredients Ingredient Name Strength ERIASTRUM FILIFOLIUM WHOLE (UNII: 73504LI1RE) CHRYSANTHEMIC ACID, (+/-)- (UNII: 774IH300I2) LONICERA CONFUSA FLOWER (UNII: 3JV904IJ0V) SIRAITIA GROSVENORII FRUIT (UNII: NOU2FB51TW) CELOSIA CRISTATA WHOLE (UNII: 8AD23I251Q) RHEUM OFFICINALE WHOLE (UNII: VC3KP6B2CE) CHLORHEXIDINE ACETATE (UNII: 5908ZUF22Y) Product Characteristics Color Score Shape Size Flavor FRUIT Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:54465-001-01 15 L in 1 BOTTLE; Type 0: Not a Combination Product 04/15/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 04/15/2020 Labeler - Shenzhen Roselle Bio-Technology Holding Co.,Ltd. (544587508) Establishment Name Address ID/FEI Business Operations Shenzhen Roselle Bio-Technology Holding Co.,Ltd. 544587508 manufacture(54465-001)
