Indications and uses
aids in the prevention of dental cavities.
Amerfresh
- Manufacturer
- Yangzhou SION Commodity Co.,Ltd
- Effective date
- 2023-12-08
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 10
- Source
- full-release
- Hydrated at
- 2026-06-01 00:03:37
Label at a glance#
ProductAmerfresh
Active ingredientSODIUM MONOFLUOROPHOSPHATE
Label structure6 sections
Dosage and administration
do not swallow . supervise children as necessary until capable of useing without supervision instruct children under 12 years of age in good brushing and rinsing habits(to minimize swallowing). Adults and children 6 years of age and older:Brush teeth thoroughly,preferably after each meal or at least twice a day,or as directed by a dentist or a physician. Children under 6 years of age:do not use unless directed by ...
Label contents#
Full prescribing information#
Active ingredients
Sodium monofluorophosphate 0.22%(0.1 w/v Fluoride ion)
Purpose
anticavity
Uses
aids in the prevention of dental cavities.
Warnings
Keep out of the reach of children under 6 years of age.if more than used for brushing is accidently swallowed,get medical help or contact a Poison Control Center immediately.
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
Keep out of reach of children.
Directions
do not swallow .
supervise children as necessary until capable of useing without supervision
instruct children under 12 years of age in good brushing and rinsing habits(to minimize swallowing).
Adults and children 6 years of age and older:Brush teeth thoroughly,preferably after each meal or at least twice a day,or as directed by a dentist or a physician.
Children under 6 years of age:do not use unless directed by a doctor or dentist.
INACTIVE INGREDIENT
calcium carbonate,water,sorbitol,hydrated silica,sodium lauryl sulfate,sodium carboxymethyl cellulose,flavor,sodium sacharine,polymethylene glycol,guar gum,methylisothiazolinone.
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 70766-003-01 | Amerfresh | 17 g in 1 TUBE | PASTE | 17 | 10 | |
| 70766-003-01 | Amerfresh | 144 in 1 BOX | PASTE | 144 | 10 | |
| 70766-003-02 | Amerfresh | 144 in 1 BOX | PASTE | 144 | 10 | |
| 70766-003-02 | Amerfresh | 24 g in 1 TUBE | PASTE | 24 | 10 | |
| 70766-003-03 | Amerfresh | 144 in 1 BOX | PASTE | 144 | 10 | |
| 70766-003-03 | Amerfresh | 43 g in 1 TUBE | PASTE | 43 | 10 | |
| 70766-003-04 | Amerfresh | 144 in 1 BOX | PASTE | 144 | 10 | |
| 70766-003-04 | Amerfresh | 78 g in 1 TUBE | PASTE | 78 | 10 | |
| 70766-003-05 | Amerfresh | 85 g in 1 TUBE | PASTE | 85 | 10 | |
| 70766-003-05 | Amerfresh | 144 in 1 BOX | PASTE | 144 | 10 | |
| 70766-003-06 | Amerfresh | 142 g in 1 TUBE | PASTE | 142 | 10 | |
| 70766-003-06 | Amerfresh | 144 in 1 BOX | PASTE | 144 | 10 | |
| 70766-003-07 | Amerfresh | 7 g in 1 BAG | PASTE | 7 | 10 | |
| 70766-003-07 | Amerfresh | 1000 in 1 BOX | PASTE | 1000 | 10 | |
| 70766-003-08 | Amerfresh | 5 in 1 CARTON | PASTE | 5 | 10 | |
| 70766-003-08 | Amerfresh | 144 in 1 BOX | PASTE | 144 | 10 | |
| 70766-003-09 | Amerfresh | 5 in 1 CARTON | PASTE | 5 | 10 | |
| 70766-003-09 | Amerfresh | 144 in 1 BOX | PASTE | 144 | 10 | |
| 70766-003-10 | Amerfresh | 7.1 g in 1 BAG | PASTE | 7.1 | 10 | |
| 70766-003-10 | Amerfresh | 1000 in 1 BOX | PASTE | 1000 | 10 | |
| 70766-003-11 | Amerfresh | 72 in 1 BOX | PASTE | 72 | 10 | |
| 70766-003-11 | Amerfresh | 142 g in 1 TUBE | PASTE | 142 | 10 | |
| 70766-003-12 | Amerfresh | 181 g in 1 TUBE | PASTE | 181 | 10 | |
| 70766-003-12 | Amerfresh | 72 in 1 BOX | PASTE | 72 | 10 | |
| 70766-003-13 | Amerfresh | 125 in 1 BOX | PASTE | 125 | 10 | |
| 70766-003-13 | Amerfresh | 4 in 1 CARTON | PASTE | 4 | 10 |
DailyMed Dashboard NDC Coverage#
Products#
Every source-derived product name is available through these pages.
- Amerfresh
- Sodium Fluoride
- GUAR GUM
- POTASSIUM SODIUM SACCHARATE
- CALCIUM CARBONATE
- SORBITOL
- HYDRATED SILICA
- METHYLENE GLYCOL
- WATER
- SODIUM LAURYL SULFATE
- DISODIUM CARBOXYMETHYLARSONATE
- METHYLISOTHIAZOLINONE
- SODIUM MONOFLUOROPHOSPHATE
- FLUORIDE ION
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 70766-003 | 70766-003-01, 70766-003-02, 70766-003-03, 70766-003-04, 70766-003-05, 70766-003-06, 70766-003-07, 70766-003-10, 70766-003-08, 70766-003-09, 70766-003-11, 70766-003-12, 70766-003-13 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| GUAR GUM | E89I1637KE | IACT |
| POTASSIUM SODIUM SACCHARATE | 73U34YC90U | IACT |
| CALCIUM CARBONATE | H0G9379FGK | IACT |
| SORBITOL | 506T60A25R | IACT |
| HYDRATED SILICA | Y6O7T4G8P9 | IACT |
| METHYLENE GLYCOL | 6Z20YM9257 | IACT |
| WATER | 059QF0KO0R | IACT |
| SODIUM LAURYL SULFATE | 368GB5141J | IACT |
| DISODIUM CARBOXYMETHYLARSONATE | T9HTL93NB7 | IACT |
| METHYLISOTHIAZOLINONE | 229D0E1QFA | IACT |
| SODIUM MONOFLUOROPHOSPHATE | C810JCZ56Q | ACTIM |
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 |
|---|---|---|---|---|---|---|
| 0bf9c0df-767a-3060-e063-6394a90a16c7 | 41f32cae-e80d-2e25-e054-00144ff8d46c | 2023-12-08 | Warnings | 0bf9c0df-767a-3060-e063-6394a90a16c7 41f32cae-e80d-2e25-e054-00144ff8d46c |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.