OTC - ACTIVE INGREDIENT SECTION
Active ingredients: Sodium monofluorophosphate 0.21g/30g
Anti caries
- Manufacturer
- Fujian Youxi Sanmiao Trading Co., Ltd.
- Effective date
- 2024-11-07
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 1
- Source
- full-release
- Hydrated at
- 2026-06-01 00:35:23
Label at a glance#
ProductAnti caries
Active ingredientSODIUM FLUORIDE
Label structure8 sections
Label contents#
Full prescribing information#
OTC - PURPOSE SECTION
Purpose: Toothpaste for protecting teeth
INDICATIONS & USAGE SECTION
1. Prevent tooth decay: During the brushing process, fluoride can be attached to the surface of the teeth to form a protective layer to prevent bacterial erosion.
2. Clean dental plaque: Fluoride has a redox effect, which can make the dental plaque attached to the surface of the teeth fall off.
WARNINGS SECTION
Warnings section
For external use only. Keep out of reach of children. Avoidcontact with eyes. Discontinue use if signs of irritation or rash occur.
DOSAGE & ADMINISTRATION SECTION
Dosage & administration section
Squeeze an appropriate amount of paste onto a toothbrush and gently scrub teeth and tongue for 2-3 minutes to leave them clean and refreshed.
INACTIVE INGREDIENT SECTION
INACTIVE INGREDIENTS:
GLYCERIN, AQuA, HYDRATED SILICA, POLYSORBATE S0, CELLULOSE GUM,MENTHAPIPERITA(PEPPERMINT) OL, PHENOXYETHANOL, sUCRALOSE, TETRASODUMPYROPHOSPHATE, CI17200/D&C RED NO.33, C1 42090/FD&C BLUE NO.1, ETHYLHEXYLGLYCERIN.
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
For external use only. Keep out of reach of children. Avoidcontact with eyes. Discontinue use if signs of irritation or rash occur.
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 84518-005-11 | Anti caries | 30 g in 1 BOX | PASTE | 30 | 1 | |
| 84518-005-12 | Anti caries | 1 in 1 BOTTLE | PASTE | 1 | 1 |
DailyMed Dashboard NDC Coverage#
Products#
Every source-derived product name is available through these pages.
- Anti caries
- Sodium monofluorophosphate
- GLYCERIN
- HYDRATED SILICA
- WATER
- TETRASODIUM PYROPHOSPHATE
- SODIUM FLUORIDE
- FLUORIDE ION
- D&C RED NO. 33
- POLAWAX POLYSORBATE
- ETHYLHEXYLGLYCERIN
- PHENOXYETHANOL
- CELLULOSE GUM
- MENTHOL, UNSPECIFIED FORM
- FD&C BLUE NO. 1
- SUCRALOSE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 84518-005 | 84518-005-11, 84518-005-12 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| GLYCERIN | PDC6A3C0OX | IACT |
| HYDRATED SILICA | Y6O7T4G8P9 | IACT |
| WATER | 059QF0KO0R | IACT |
| TETRASODIUM PYROPHOSPHATE | O352864B8Z | IACT |
| SODIUM FLUORIDE | 8ZYQ1474W7 | ACTIB |
| D&C RED NO. 33 | 9DBA0SBB0L | IACT |
| POLAWAX POLYSORBATE | Q504PL8E0V | IACT |
| ETHYLHEXYLGLYCERIN | 147D247K3P | IACT |
| PHENOXYETHANOL | HIE492ZZ3T | IACT |
| CELLULOSE GUM | K679OBS311 | IACT |
| MENTHOL, UNSPECIFIED FORM | L7T10EIP3A | IACT |
| FD&C BLUE NO. 1 | H3R47K3TBD | IACT |
| SUCRALOSE | 96K6UQ3ZD4 | IACT |
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 |
|---|---|---|---|---|---|---|
| 26518e95-ce5a-0d05-e063-6294a90a858e | 26518e95-ce59-0d05-e063-6294a90a858e | 2024-11-07 | Warnings | 26518e95-ce5a-0d05-e063-6294a90a858e 26518e95-ce59-0d05-e063-6294a90a858e |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.