AmerFresh Tooth

Manufacturer: Yangzhou SION Commodity Co.,Ltd | Yangzhou SION Commodity Co., Ltd
Effective date: 2023-12-08
Label type: HUMAN OTC DRUG LABEL
Version: 6
Source: full-release
Hydrated at: 2026-06-01 00:44:04

Label at a glance#

ProductAmerFresh Tooth

Active ingredientSODIUM MONOFLUOROPHOSPHATE

Label structure6 sections

Indications and uses

aids in the prevention of dental cavities.

Dosage and administration

For Use: Wet toothbrush and dip into powder until brush is fully covered 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 ...

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

SODIUM MONOFLUOROPHOSPHATE 0.76%(0.1 w/v Fluoride ion)

Purpose

OTC - PURPOSE SECTION

anticavity

Uses

INDICATIONS & USAGE SECTION

aids in the prevention of dental cavities.

Warnings

WARNINGS SECTION

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

DOSAGE & ADMINISTRATION SECTION

For Use:

Wet toothbrush and dip into powder until brush is fully covered
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

INACTIVE INGREDIENT SECTION

calcium carbonate, silica,sodium lauryl sulfate, flavor, sodium sacharine, methylisothiazolinone

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
70766-005-01	2026-01-29	C162847	48780-1	d6a99b39-6753-a426-e053-dadaa90af4c2	70766-005 Amerfresh Fluoride Toothpaste
70766-005-02	2026-01-29	C162847	48780-1	d6a99b39-6753-a426-e053-dadaa90af4c2	70766-005 Amerfresh Fluoride Toothpaste
70766-005-01	2024-12-16	C162847	48780-1	d6a99b39-6753-a426-e053-dadaa90af4c2	70766-005 Amerfresh Fluoride Toothpaste
70766-005-02	2024-12-16	C162847	48780-1	d6a99b39-6753-a426-e053-dadaa90af4c2	70766-005 Amerfresh Fluoride Toothpaste
70766-005-01	2022-01-28	C162847	48780-1	d6a99b39-6753-a426-e053-dadaa90af4c2	70766-005 Amerfresh Fluoride Toothpaste
70766-005-02	2022-01-28	C162847	48780-1	d6a99b39-6753-a426-e053-dadaa90af4c2	70766-005 Amerfresh Fluoride Toothpaste

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
70766-005-01	AmerFresh Tooth	40 in 1 CARTON	POWDER	40	6
70766-005-01	AmerFresh Tooth	454 g in 1 PACKAGE	POWDER	454	6
70766-005-02	AmerFresh Tooth	50 in 1 BOX	POWDER	50	6
70766-005-02	AmerFresh Tooth	4 in 1 CARTON	POWDER	4	6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
70766-005	AMERFRESH TOOTH (SODIUM MONOFLUOROPHOSPHATE) POWDER [YANGZHOU SION COMMODITY CO.,LTD]	6	Legacy NDC, 4 package rows	20241218_f108b86c-cb5e-4768-83e7-9d580bc42eac.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 8 matching rows.

AmerFresh Tooth
SODIUM MONOFLUOROPHOSPHATE
POTASSIUM SODIUM SACCHARATE
CALCIUM CARBONATE
METHYLISOTHIAZOLINONE
HYDRATED SILICA
SODIUM LAURYL SULFATE
FLUORIDE ION

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
70766-005	70766-005-01, 70766-005-02

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 6 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
POTASSIUM SODIUM SACCHARATE	73U34YC90U	IACT
CALCIUM CARBONATE	H0G9379FGK	IACT
METHYLISOTHIAZOLINONE	229D0E1QFA	IACT
HYDRATED SILICA	Y6O7T4G8P9	IACT
SODIUM LAURYL SULFATE	368GB5141J	IACT
SODIUM MONOFLUOROPHOSPHATE	C810JCZ56Q	ACTIM

Source Document#

Source XML

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.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
0bf9dc10-06e1-0ebc-e063-6294a90a734a			f108b86c-cb5e-4768-83e7-9d580bc42eac	2023-12-08	Warnings	Exact identifier spl id: 0bf9dc10-06e1-0ebc-e063-6294a90a734a spl set id: f108b86c-cb5e-4768-83e7-9d580bc42eac

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.