Amerfresh Clear

Manufacturer: Amercare Products Inc
Effective date: 2011-03-16
Label type: HUMAN OTC DRUG LABEL
Version: 1
Source: full-release
Hydrated at: 2026-05-31 22:27:36

Label at a glance#

ProductAmerfresh Clear

Active ingredientSodium Fluoride

Label structure9 sections

Dosage and administration

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 2 to 6 years use only a pea sized amount and supervise child's brushing and rinsing to minimize swallowing. Children under 2 years Ask a dentist or physician.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

FLUORIDE gel TOOTHPASTE

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Sodium Fluoride 0.22% (0.1% w/v fluoride ion)

Purpose

OTC - PURPOSE SECTION

Anticavity

Use

INDICATIONS & USAGE SECTION

helps protect against cavities.

Warning

WARNINGS SECTION

OTC - KEEP OUT OF REACH OF CHILDREN 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 centre immediately.

Directions

DOSAGE & ADMINISTRATION SECTION

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 2 to 6 years	use only a pea sized amount and supervise child's brushing and rinsing to minimize swallowing.
Children under 2 years	Ask a dentist or physician.

Inactive Ingredient

INACTIVE INGREDIENT SECTION

Sorbitol, Silica, Methyl Paraben Sodium, Propyl Paraben Sodium, Flavour, Sodium Saccharin, Treated water, SCMC, Sodium Lauryl Sulfate.

SPL UNCLASSIFIED SECTION

Exclusive Distributor: AMERCARE Products Inc. Seattle. WA 98165-2226.

PRINCIPAL DISPLAY PANEL - 181 g Carton Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

AMERFRESH^®

FLUORIDE gel TOOTHPASTE

NET WT. 6.4 oz (181g)

PRINCIPAL DISPLAY PANEL - 181 g Carton Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
245598	sodium fluoride 0.22 % Toothpaste	PSN	1
245598	sodium fluoride 0.0022 MG/MG Toothpaste	SCD	1
245598	sodium fluoride 0.22 % (fluoride 0.1 % ) Toothpaste	SY	1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
51460-5010-1	2019-10-29	C162847	48780-1	960f7f55-d7e4-8e05-e053-dbdaa90a074a	AMERFRESH ®
51460-5010-2	2019-10-29	C162847	48780-1	960f7f55-d7e4-8e05-e053-dbdaa90a074a	AMERFRESH ®
51460-5010-3	2019-10-29	C162847	48780-1	960f7f55-d7e4-8e05-e053-dbdaa90a074a	AMERFRESH ®
51460-5010-4	2019-10-29	C162847	48780-1	960f7f55-d7e4-8e05-e053-dbdaa90a074a	AMERFRESH ®
51460-5010-5	2019-10-29	C162847	48780-1	960f7f55-d7e4-8e05-e053-dbdaa90a074a	AMERFRESH ®

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
51460-5010-1	Amerfresh Clear	85 g in 1 TUBE	PASTE, DENTIFRICE	85	1
51460-5010-2	Amerfresh Clear	42 g in 1 TUBE	PASTE, DENTIFRICE	42	1
51460-5010-3	Amerfresh Clear	24 g in 1 TUBE	PASTE, DENTIFRICE	24	1
51460-5010-4	Amerfresh Clear	17 g in 1 TUBE	PASTE, DENTIFRICE	17	1
51460-5010-5	Amerfresh Clear	181 g in 1 TUBE	PASTE, DENTIFRICE	181	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
51460-5010	AMERFRESH CLEAR (SODIUM FLUORIDE) PASTE, DENTIFRICE [AMERCARE PRODUCTS INC]	1	Legacy NDC, 5 package rows	20110330_bed07ba9-14ed-4dda-9bd9-49dfc5c12129.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
Sodium Fluoride	ACTIVE INGREDIENT	8ZYQ1474W7	1
Fluoride Ion	ACTIVE MOIETY	Q80VPU408O	1
Carboxymethylcellulose Sodium	INACTIVE INGREDIENT	K679OBS311	1
Methylparaben Sodium	INACTIVE INGREDIENT	CR6K9C2NHK	1
Propylparaben Sodium	INACTIVE INGREDIENT	625NNB0G9N	1
Saccharin Sodium	INACTIVE INGREDIENT	SB8ZUX40TY	1
Silicon Dioxide	INACTIVE INGREDIENT	ETJ7Z6XBU4	1
Sodium Lauryl Sulfate	INACTIVE INGREDIENT	368GB5141J	1
Sorbitol	INACTIVE INGREDIENT	506T60A25R	1
Water	INACTIVE INGREDIENT	059QF0KO0R	1

Products#

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

DailyMed product names page 1 of 1 · 11 matching rows.

Amerfresh Clear
Sodium Fluoride
Fluoride Ion
Sorbitol
Water
Silicon Dioxide
Sodium Lauryl Sulfate
Carboxymethylcellulose Sodium
Saccharin Sodium
Methylparaben Sodium
Propylparaben Sodium

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
51460-5010	51460-5010-1, 51460-5010-2, 51460-5010-3, 51460-5010-4, 51460-5010-5

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
Sodium Fluoride	8ZYQ1474W7	ACTIB
Sorbitol	506T60A25R	IACT
Water	059QF0KO0R	IACT
Silicon Dioxide	ETJ7Z6XBU4	IACT
Sodium Lauryl Sulfate	368GB5141J	IACT
Carboxymethylcellulose Sodium	K679OBS311	IACT
Saccharin Sodium	SB8ZUX40TY	IACT
Methylparaben Sodium	CR6K9C2NHK	IACT
Propylparaben Sodium	625NNB0G9N	IACT

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 4 · 225 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
Sodium Lauryl Sulfate	SODIUM LAURYL SULFATE	368GB5141J	TABLET, ORALLY DISINTEGRATING / ORAL		16 mg	Exact identifier — unii candidate 42 equally ranked IID candidates
Silicon Dioxide	SILICON DIOXIDE	ETJ7Z6XBU4	SYSTEM / TRANSDERMAL		35 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
Sodium Lauryl Sulfate	SODIUM LAURYL SULFATE	368GB5141J	TABLET, EXTENDED RELEASE / ORAL		320 mg	Exact identifier — unii candidate 42 equally ranked IID candidates
Carboxymethylcellulose Sodium	CARBOXYMETHYLCELLULOSE SODIUM	K679OBS311	FILM, SOLUBLE / BUCCAL		47 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
Silicon Dioxide	SILICON DIOXIDE	ETJ7Z6XBU4	CAPSULE, DELAYED RELEASE / ORAL		40 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
Sodium Lauryl Sulfate	SODIUM LAURYL SULFATE	368GB5141J	CAPSULE, COATED, EXTENDED RELEASE / ORAL	NA		Exact identifier — unii candidate 42 equally ranked IID candidates
Carboxymethylcellulose Sodium	CARBOXYMETHYLCELLULOSE SODIUM	K679OBS311	FILM / BUCCAL		18 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
Methylparaben Sodium	METHYLPARABEN SODIUM	CR6K9C2NHK	SUSPENSION / ORAL		80 mg	Exact identifier — unii candidate 6 equally ranked IID candidates
Carboxymethylcellulose Sodium	CARBOXYMETHYLCELLULOSE SODIUM	K679OBS311	TABLET, CHEWABLE / ORAL	24.75 mg		Exact identifier — unii candidate 44 equally ranked IID candidates
Saccharin Sodium	SACCHARIN SODIUM	SB8ZUX40TY	PASTE / DENTAL	0.3 %w/w		Exact identifier — unii candidate 34 equally ranked IID candidates
Sodium Lauryl Sulfate	SODIUM LAURYL SULFATE	368GB5141J	PASTE / DENTAL	1.5 %w/w		Exact identifier — unii candidate 42 equally ranked IID candidates
Carboxymethylcellulose Sodium	CARBOXYMETHYLCELLULOSE SODIUM	K679OBS311	SOLUTION / ORAL		3480 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
Sorbitol	SORBITOL	506T60A25R	INJECTION, SOLUTION / SUBCUTANEOUS	4.7 %w/v		Exact identifier — unii candidate 44 equally ranked IID candidates
Carboxymethylcellulose Sodium	CARBOXYMETHYLCELLULOSE SODIUM	K679OBS311	TABLET, EXTENDED RELEASE / ORAL		933 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
Saccharin Sodium	SACCHARIN SODIUM	SB8ZUX40TY	FILM / BUCCAL		3 mg	Exact identifier — unii candidate 34 equally ranked IID candidates
Sorbitol	SORBITOL	506T60A25R	INJECTION, SOLUTION / INTRAVENOUS		4050 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
Sorbitol	SORBITOL	506T60A25R	TABLET, ORALLY DISINTEGRATING / ORAL		7 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
Silicon Dioxide	SILICON DIOXIDE	ETJ7Z6XBU4	CAPSULE / ORAL		300 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
Carboxymethylcellulose Sodium	CARBOXYMETHYLCELLULOSE SODIUM	K679OBS311	SYSTEM / TOPICAL		1680 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
Sorbitol	SORBITOL	506T60A25R	SOLUTION, CONCENTRATE / ORAL	300 mg/1ml		Exact identifier — unii candidate 44 equally ranked IID candidates
Sodium Lauryl Sulfate	SODIUM LAURYL SULFATE	368GB5141J	SHAMPOO / TOPICAL	65 %w/w		Exact identifier — unii candidate 42 equally ranked IID candidates
Saccharin Sodium	SACCHARIN SODIUM	SB8ZUX40TY	AEROSOL, METERED / RESPIRATORY (INHALATION)	0.05 %w/w		Exact identifier — unii candidate 34 equally ranked IID candidates
Sorbitol	SORBITOL	506T60A25R	OINTMENT / TOPICAL	10 %w/w		Exact identifier — unii candidate 44 equally ranked IID candidates
Sodium Lauryl Sulfate	SODIUM LAURYL SULFATE	368GB5141J	TABLET, DELAYED RELEASE / ORAL		199 mg	Exact identifier — unii candidate 42 equally ranked IID candidates
Silicon Dioxide	SILICON DIOXIDE	ETJ7Z6XBU4	TABLET, EXTENDED RELEASE / ORAL		450 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
Carboxymethylcellulose Sodium	CARBOXYMETHYLCELLULOSE SODIUM	K679OBS311	CAPSULE, DELAYED RELEASE / ORAL	4.2 mg		Exact identifier — unii candidate 44 equally ranked IID candidates
Sodium Lauryl Sulfate	SODIUM LAURYL SULFATE	368GB5141J	LOTION / TOPICAL		111 mg	Exact identifier — unii candidate 42 equally ranked IID candidates
Silicon Dioxide	SILICON DIOXIDE	ETJ7Z6XBU4	GRANULE, FOR SUSPENSION / ORAL		200 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
Sorbitol	SORBITOL	506T60A25R	CREAM / TOPICAL	36.8 %w/w		Exact identifier — unii candidate 44 equally ranked IID candidates
Silicon Dioxide	SILICON DIOXIDE	ETJ7Z6XBU4	CAPSULE, COATED, EXTENDED RELEASE / ORAL	NA		Exact identifier — unii candidate 49 equally ranked IID candidates
Carboxymethylcellulose Sodium	CARBOXYMETHYLCELLULOSE SODIUM	K679OBS311	SOLUTION / TOPICAL	NA		Exact identifier — unii candidate 44 equally ranked IID candidates
Sodium Lauryl Sulfate	SODIUM LAURYL SULFATE	368GB5141J	SPRAY / TOPICAL		7 mg	Exact identifier — unii candidate 42 equally ranked IID candidates
Sodium Lauryl Sulfate	SODIUM LAURYL SULFATE	368GB5141J	GEL / VAGINAL	0.2 %w/w		Exact identifier — unii candidate 42 equally ranked IID candidates
Silicon Dioxide	SILICON DIOXIDE	ETJ7Z6XBU4	TABLET, DELAYED RELEASE PARTICLES / ORAL		170 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
Carboxymethylcellulose Sodium	CARBOXYMETHYLCELLULOSE SODIUM	K679OBS311	INJECTION, SUSPENSION / INTRAVITREAL	0.5 %w/v		Exact identifier — unii candidate 44 equally ranked IID candidates
Silicon Dioxide	SILICON DIOXIDE	ETJ7Z6XBU4	TABLET / SUBLINGUAL		10 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
Carboxymethylcellulose Sodium	CARBOXYMETHYLCELLULOSE SODIUM	K679OBS311	POWDER, FOR SUSPENSION / INTRAMUSCULAR	0.7 %w/v		Exact identifier — unii candidate 44 equally ranked IID candidates
Methylparaben Sodium	METHYLPARABEN SODIUM	CR6K9C2NHK	POWDER, FOR SUSPENSION / ORAL		80 mg	Exact identifier — unii candidate 6 equally ranked IID candidates
Silicon Dioxide	SILICON DIOXIDE	ETJ7Z6XBU4	PELLET / ORAL		34 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
Saccharin Sodium	SACCHARIN SODIUM	SB8ZUX40TY	POWDER, FOR SUSPENSION / ORAL		85 mg	Exact identifier — unii candidate 34 equally ranked IID candidates
Sorbitol	SORBITOL	506T60A25R	POWDER, FOR SUSPENSION / ORAL		12000 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
Carboxymethylcellulose Sodium	CARBOXYMETHYLCELLULOSE SODIUM	K679OBS311	TABLET, DELAYED RELEASE / ORAL		280 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
Silicon Dioxide	SILICON DIOXIDE	ETJ7Z6XBU4	CREAM / VAGINAL		51 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
Carboxymethylcellulose Sodium	CARBOXYMETHYLCELLULOSE SODIUM	K679OBS311	SYRUP / ORAL	26.5 mg		Exact identifier — unii candidate 44 equally ranked IID candidates
Saccharin Sodium	SACCHARIN SODIUM	SB8ZUX40TY	OINTMENT / TOPICAL	NA		Exact identifier — unii candidate 34 equally ranked IID candidates
Sorbitol	SORBITOL	506T60A25R	INJECTION / INTRAVENOUS		1276 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
Sorbitol	SORBITOL	506T60A25R	LOTION / TOPICAL	10.7 %w/w		Exact identifier — unii candidate 44 equally ranked IID candidates
Sorbitol	SORBITOL	506T60A25R	AEROSOL, FOAM / TOPICAL	4.95 %w/w		Exact identifier — unii candidate 44 equally ranked IID candidates
Saccharin Sodium	SACCHARIN SODIUM	SB8ZUX40TY	INJECTION / INTRAVENOUS		22 mg	Exact identifier — unii candidate 34 equally ranked IID candidates
Sorbitol	SORBITOL	506T60A25R	SOLUTION / NASAL	25 mg/1ml		Exact identifier — unii candidate 44 equally ranked IID candidates
Sodium Lauryl Sulfate	SODIUM LAURYL SULFATE	368GB5141J	GEL / TOPICAL	0.05 %w/w		Exact identifier — unii candidate 42 equally ranked IID candidates
Sodium Lauryl Sulfate	SODIUM LAURYL SULFATE	368GB5141J	PELLET / ORAL		2 mg	Exact identifier — unii candidate 42 equally ranked IID candidates
Sodium Lauryl Sulfate	SODIUM LAURYL SULFATE	368GB5141J	POWDER / RESPIRATORY (INHALATION)	NA		Exact identifier — unii candidate 42 equally ranked IID candidates
Silicon Dioxide	SILICON DIOXIDE	ETJ7Z6XBU4	GEL / NASAL		20 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
Sorbitol	SORBITOL	506T60A25R	INJECTION / INTRALESIONAL	45 %w/v		Exact identifier — unii candidate 44 equally ranked IID candidates
Sodium Lauryl Sulfate	SODIUM LAURYL SULFATE	368GB5141J	GRANULE / ORAL		12 mg	Exact identifier — unii candidate 42 equally ranked IID candidates
Saccharin Sodium	SACCHARIN SODIUM	SB8ZUX40TY	TABLET / RECTAL	0.6 mg		Exact identifier — unii candidate 34 equally ranked IID candidates
Sorbitol	SORBITOL	506T60A25R	CREAM, AUGMENTED / TOPICAL	15 %w/w		Exact identifier — unii candidate 44 equally ranked IID candidates
Carboxymethylcellulose Sodium	CARBOXYMETHYLCELLULOSE SODIUM	K679OBS311	INJECTION / INTRAMUSCULAR		30 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
Sorbitol	SORBITOL	506T60A25R	SOLUTION / OPHTHALMIC		6 mg	Exact identifier — unii candidate 44 equally ranked IID candidates

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
27b8a829-d438-439c-b6f5-710cb8e2de7a			bed07ba9-14ed-4dda-9bd9-49dfc5c12129	2011-03-16	Warnings	Exact identifier spl id: 27b8a829-d438-439c-b6f5-710cb8e2de7a spl set id: bed07ba9-14ed-4dda-9bd9-49dfc5c12129

Reported adverse events (FAERS/openFDA)#

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