DOSAGE & ADMINISTRATION SECTION
Please store this product in a dry place at room temperature.
Toothy Oral Solution
- Manufacturer
- Shenzhen Roselle Bio-Technology Holding Co.,Ltd.
- Effective date
- 2020-04-15
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 1
- Source
- full-release
- Hydrated at
- 2026-05-31 23:06:22
Label at a glance#
ProductToothy Oral Solution
Active ingredientSOPHORA FLAVESCENS WHOLE, HOUTTUYNIA CORDATA WHOLE
Label structure8 sections
Label contents#
Full prescribing information#
INACTIVE INGREDIENT SECTION
Momordica grosvenori
Chrysanthemum
Lavender
Honeysuckle
Cockscomb
Rheum officinale
Chlorhexidine acetate
INDICATIONS & USAGE SECTION
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.
OTC - ACTIVE INGREDIENT SECTION
Sophora flower
Houttuynia cordata
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
keep out of children
OTC - PURPOSE SECTION
Disinfection
Sterilization
WARNINGS SECTION
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.
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 6c13b22c-b3ba-4127-b768-0132dd5ab0d1 | Product name | 1 | 20230829 |
| bb6d6c68-649d-4e6d-a1f6-603d969c8f68 | Product name | 1 | 20160303 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 54465-001-01 | 2022-01-28 | C162847 | 48780-1 | d6a99b39-d67d-a426-e053-dadaa90af4c2 | a35029bf-b6cb-c5ef-e053-2a95a90ab729 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 54465-001-01 | Toothy Oral Solution | 15 L in 1 BOTTLE | LIQUID | 15 | 1 |
DailyMed Dashboard NDC Coverage#
Products#
Every source-derived product name is available through these pages.
- Toothy Oral Solution
- Toothy Oral Expert
- SOPHORA FLAVESCENS WHOLE
- ERIASTRUM FILIFOLIUM WHOLE
- HOUTTUYNIA CORDATA WHOLE
- CHRYSANTHEMIC ACID, (+/-)-
- LONICERA CONFUSA FLOWER
- SIRAITIA GROSVENORII FRUIT
- CELOSIA CRISTATA WHOLE
- RHEUM OFFICINALE WHOLE
- CHLORHEXIDINE ACETATE
- CHLORHEXIDINE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 54465-001 | 54465-001-01 |
Ingredients#
Every source-derived ingredient row is available through these pages.
Source Document#
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| a35029bf-b6cc-c5ef-e053-2a95a90ab729 | a35029bf-b6cb-c5ef-e053-2a95a90ab729 | 2020-04-15 | Warnings | a35029bf-b6cc-c5ef-e053-2a95a90ab729 a35029bf-b6cb-c5ef-e053-2a95a90ab729 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.