Charm-Tex FLUORIDE GEL TOOTHPASTE

Manufacturer: Charm Tex, Inc.
Effective date: 2011-12-29
Label type: HUMAN OTC DRUG LABEL
Version: 1
Source: full-release
Hydrated at: 2026-05-31 22:30:32

Label at a glance#

ProductCharm Tex

Active ingredientSodium Fluoride

Label structure9 sections

Dosage and administration

brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or a physician. Use only a pea sized amount and supervise child's brushing and rinsing to minimize swallowing. Ask a dentist or physician.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

DRUG FACTS

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.

OTC - WHEN USING SECTION

If more than used for brushing is accidently swallowed, get medical help or contact a poison control centre immediately.

Inactive ingredient

INACTIVE INGREDIENT SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

Adults and children 6 years of age and older

SPL UNCLASSIFIED SECTION

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

SPL UNCLASSIFIED SECTION

Use only a pea sized amount and supervise child's brushing and rinsing to minimize swallowing.

Children under 2 years

SPL UNCLASSIFIED SECTION

Ask a dentist or physician.

SPL UNCLASSIFIED SECTION

Exclusive Distributor: Charm-Tex, Inc. USA

PRINCIPAL DISPLAY PANEL - 42.5 Grams Tube Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Charm-Tex

FLUORIDE GEL TOOTHPASTE

Net Wt. 1.5 oz.
42.5 Grams

PRINCIPAL DISPLAY PANEL - 42.5 Grams Tube 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
40057-1001-1	2019-11-13	C162847	48780-1	97449f38-bdf5-f6ea-e053-dbdaa90aa703	Charm-Tex FLUORIDE GEL TOOTHPASTE
40057-1001-2	2019-11-13	C162847	48780-1	97449f38-bdf5-f6ea-e053-dbdaa90aa703	Charm-Tex FLUORIDE GEL TOOTHPASTE
40057-1001-3	2019-11-13	C162847	48780-1	97449f38-bdf5-f6ea-e053-dbdaa90aa703	Charm-Tex FLUORIDE GEL TOOTHPASTE
40057-1001-4	2019-11-13	C162847	48780-1	97449f38-bdf5-f6ea-e053-dbdaa90aa703	Charm-Tex FLUORIDE GEL TOOTHPASTE
40057-1001-5	2019-11-13	C162847	48780-1	97449f38-bdf5-f6ea-e053-dbdaa90aa703	Charm-Tex FLUORIDE GEL TOOTHPASTE
40057-1001-6	2019-11-13	C162847	48780-1	97449f38-bdf5-f6ea-e053-dbdaa90aa703	Charm-Tex FLUORIDE GEL TOOTHPASTE

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
40057-1001-1	Charm Tex	141 g in 1 TUBE	PASTE, DENTIFRICE	141	1
40057-1001-2	Charm Tex	85 g in 1 TUBE	PASTE, DENTIFRICE	85	1
40057-1001-3	Charm Tex	42.5 g in 1 TUBE	PASTE, DENTIFRICE	42.5	1
40057-1001-4	Charm Tex	24 g in 1 TUBE	PASTE, DENTIFRICE	24	1
40057-1001-5	Charm Tex	17 g in 1 TUBE	PASTE, DENTIFRICE	17	1
40057-1001-6	Charm Tex	4.24 g in 1 POUCH	PASTE, DENTIFRICE	4.24	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
40057-1001	CHARM TEX (SODIUM FLUORIDE) PASTE, DENTIFRICE [CHARM TEX, INC.]	1	Legacy NDC, 6 package rows	20120106_3579fd94-ee49-4608-94dc-401b66a78ec2.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 Dihydrate	INACTIVE INGREDIENT	SB8ZUX40TY	1
Silicon Dioxide	INACTIVE INGREDIENT	ETJ7Z6XBU4	1
Sodium Lauryl Sulfate	INACTIVE INGREDIENT	368GB5141J	1
Sorbitol	INACTIVE INGREDIENT	506T60A25R	1

Products#

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

DailyMed product names page 1 of 1 · 10 matching rows.

Charm Tex
Sodium Fluoride
Fluoride Ion
Sorbitol
Silicon Dioxide
Sodium Lauryl Sulfate
Carboxymethylcellulose Sodium
Saccharin Sodium Dihydrate
Methylparaben Sodium
Propylparaben Sodium

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
40057-1001	40057-1001-1, 40057-1001-2, 40057-1001-3, 40057-1001-4, 40057-1001-5, 40057-1001-6

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
Sodium Fluoride	8ZYQ1474W7	ACTIB
Sorbitol	506T60A25R	IACT
Silicon Dioxide	ETJ7Z6XBU4	IACT
Sodium Lauryl Sulfate	368GB5141J	IACT
Carboxymethylcellulose Sodium	K679OBS311	IACT
Saccharin Sodium Dihydrate	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
Saccharin Sodium Dihydrate	SACCHARIN SODIUM	SB8ZUX40TY	SOLUTION / RESPIRATORY (INHALATION)	NA		Exact identifier — unii candidate 34 equally ranked IID candidates
Sorbitol	SORBITOL	506T60A25R	SYSTEM / TOPICAL		6300 mg	Exact identifier — unii candidate 44 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	TABLET, ORALLY DISINTEGRATING / ORAL		7 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
Sodium Lauryl Sulfate	SODIUM LAURYL SULFATE	368GB5141J	CAPSULE, DELAYED RELEASE / ORAL		46 mg	Exact identifier — unii candidate 42 equally ranked IID candidates
Methylparaben Sodium	METHYLPARABEN SODIUM	CR6K9C2NHK	TABLET / ORAL	0.19 mg		Exact identifier — unii candidate 6 equally ranked IID candidates
Carboxymethylcellulose Sodium	CARBOXYMETHYLCELLULOSE SODIUM	K679OBS311	FILM / BUCCAL		18 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
Sodium Lauryl Sulfate	SODIUM LAURYL SULFATE	368GB5141J	CREAM / VAGINAL		12 mg	Exact identifier — unii candidate 42 equally ranked IID candidates
Carboxymethylcellulose Sodium	CARBOXYMETHYLCELLULOSE SODIUM	K679OBS311	GRANULE, FOR SUSPENSION / ORAL	15.63 mg/5ml		Exact identifier — unii candidate 44 equally ranked IID candidates
Sodium Lauryl Sulfate	SODIUM LAURYL SULFATE	368GB5141J	DROPS / ORAL	NA		Exact identifier — unii candidate 42 equally ranked IID candidates
Sorbitol	SORBITOL	506T60A25R	CREAM / TOPICAL	36.8 %w/w		Exact identifier — unii candidate 44 equally ranked IID candidates
Sorbitol	SORBITOL	506T60A25R	GUM, CHEWING / ORAL		6168 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
Sorbitol	SORBITOL	506T60A25R	CAPSULE / ORAL		1111 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
Silicon Dioxide	SILICON DIOXIDE	ETJ7Z6XBU4	GRANULE, FOR SUSPENSION, EXTENDED RELEASE / ORAL	NA		Exact identifier — unii candidate 49 equally ranked IID candidates
Saccharin Sodium Dihydrate	SACCHARIN SODIUM	SB8ZUX40TY	WAFER / ORAL	8 mg		Exact identifier — unii candidate 34 equally ranked IID candidates
Saccharin Sodium Dihydrate	SACCHARIN SODIUM	SB8ZUX40TY	SOLUTION / ORAL		665 mg	Exact identifier — unii candidate 34 equally ranked IID candidates
Silicon Dioxide	SILICON DIOXIDE	ETJ7Z6XBU4	GRANULE / ORAL	5000 mg		Exact identifier — unii candidate 49 equally ranked IID candidates
Silicon Dioxide	SILICON DIOXIDE	ETJ7Z6XBU4	FILM, EXTENDED RELEASE / TRANSDERMAL	49 mg		Exact identifier — unii candidate 49 equally ranked IID candidates
Saccharin Sodium Dihydrate	SACCHARIN SODIUM	SB8ZUX40TY	TABLET, CHEWABLE / ORAL		84 mg	Exact identifier — unii candidate 34 equally ranked IID candidates
Sorbitol	SORBITOL	506T60A25R	SOLUTION/ DROPS / OPHTHALMIC	0.25 %w/v		Exact identifier — unii candidate 44 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
Sorbitol	SORBITOL	506T60A25R	TABLET, DELAYED RELEASE / ORAL	0.01 mg		Exact identifier — unii candidate 44 equally ranked IID candidates
Carboxymethylcellulose Sodium	CARBOXYMETHYLCELLULOSE SODIUM	K679OBS311	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAMUSCULAR		5 mg	Exact identifier — unii candidate 44 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
Sodium Lauryl Sulfate	SODIUM LAURYL SULFATE	368GB5141J	SPONGE / TOPICAL	5 %w/w		Exact identifier — unii candidate 42 equally ranked IID candidates
Sodium Lauryl Sulfate	SODIUM LAURYL SULFATE	368GB5141J	TABLET, COATED / ORAL		123 mg	Exact identifier — unii candidate 42 equally ranked IID candidates
Carboxymethylcellulose Sodium	CARBOXYMETHYLCELLULOSE SODIUM	K679OBS311	GRANULE / ORAL	NA		Exact identifier — unii candidate 44 equally ranked IID candidates
Sodium Lauryl Sulfate	SODIUM LAURYL SULFATE	368GB5141J	GEL / DENTAL	1.47 %w/w		Exact identifier — unii candidate 42 equally ranked IID candidates
Methylparaben Sodium	METHYLPARABEN SODIUM	CR6K9C2NHK	SUSPENSION / ORAL		80 mg	Exact identifier — unii candidate 6 equally ranked IID candidates
Sodium Lauryl Sulfate	SODIUM LAURYL SULFATE	368GB5141J	TABLET / ORAL		233 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
Saccharin Sodium Dihydrate	SACCHARIN SODIUM	SB8ZUX40TY	INJECTION / INTRAVENOUS		22 mg	Exact identifier — unii candidate 34 equally ranked IID candidates
Saccharin Sodium Dihydrate	SACCHARIN SODIUM	SB8ZUX40TY	SUSPENSION / ORAL	5000 mg/5ml		Exact identifier — unii candidate 34 equally ranked IID candidates
Silicon Dioxide	SILICON DIOXIDE	ETJ7Z6XBU4	POWDER / ORAL		602 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
Propylparaben Sodium	PROPYLPARABEN SODIUM	625NNB0G9N	SUSPENSION / ORAL		16 mg	Exact identifier — unii candidate 6 equally ranked IID candidates
Saccharin Sodium Dihydrate	SACCHARIN SODIUM	SB8ZUX40TY	SYRUP / ORAL		24 mg	Exact identifier — unii candidate 34 equally ranked IID candidates
Saccharin Sodium Dihydrate	SACCHARIN SODIUM	SB8ZUX40TY	AEROSOL, METERED / RESPIRATORY (INHALATION)	0.05 %w/w		Exact identifier — unii candidate 34 equally ranked IID candidates
Saccharin Sodium Dihydrate	SACCHARIN SODIUM	SB8ZUX40TY	FILM, SOLUBLE / BUCCAL		2 mg	Exact identifier — unii candidate 34 equally ranked IID candidates
Sodium Lauryl Sulfate	SODIUM LAURYL SULFATE	368GB5141J	TABLET, ORALLY DISINTEGRATING / ORAL		16 mg	Exact identifier — unii candidate 42 equally ranked IID candidates
Carboxymethylcellulose Sodium	CARBOXYMETHYLCELLULOSE SODIUM	K679OBS311	POWDER, FOR SUSPENSION / ORAL		560 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
Saccharin Sodium Dihydrate	SACCHARIN SODIUM	SB8ZUX40TY	ELIXIR / ORAL	15 mg/5ml		Exact identifier — unii candidate 34 equally ranked IID candidates
Saccharin Sodium Dihydrate	SACCHARIN SODIUM	SB8ZUX40TY	FILM / BUCCAL		3 mg	Exact identifier — unii candidate 34 equally ranked IID candidates
Sorbitol	SORBITOL	506T60A25R	SUSPENSION / ORAL		45000 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
Sodium Lauryl Sulfate	SODIUM LAURYL SULFATE	368GB5141J	CAPSULE, COATED PELLETS / ORAL		1 mg	Exact identifier — unii candidate 42 equally ranked IID candidates
Methylparaben Sodium	METHYLPARABEN SODIUM	CR6K9C2NHK	SOLUTION / ORAL		134 mg	Exact identifier — unii candidate 6 equally ranked IID candidates
Carboxymethylcellulose Sodium	CARBOXYMETHYLCELLULOSE SODIUM	K679OBS311	LOTION / TOPICAL	NA		Exact identifier — unii candidate 44 equally ranked IID candidates
Silicon Dioxide	SILICON DIOXIDE	ETJ7Z6XBU4	CAPSULE, LIQUID FILLED / ORAL		106 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
Sodium Lauryl Sulfate	SODIUM LAURYL SULFATE	368GB5141J	SHAMPOO, SUSPENSION / TOPICAL	40 %w/v		Exact identifier — unii candidate 42 equally ranked IID candidates
Sorbitol	SORBITOL	506T60A25R	INJECTION / INTRAVENOUS		1276 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
Carboxymethylcellulose Sodium	CARBOXYMETHYLCELLULOSE SODIUM	K679OBS311	SUSPENSION / ENTERAL		2920 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
Sodium Lauryl Sulfate	SODIUM LAURYL SULFATE	368GB5141J	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL		3 mg	Exact identifier — unii candidate 42 equally ranked IID candidates
Sorbitol	SORBITOL	506T60A25R	INJECTION / SUBCUTANEOUS	4.7 %w/v		Exact identifier — unii candidate 44 equally ranked IID candidates
Carboxymethylcellulose Sodium	CARBOXYMETHYLCELLULOSE SODIUM	K679OBS311	INJECTION / INTRASYNOVIAL	0.1 %w/v		Exact identifier — unii candidate 44 equally ranked IID candidates
Sorbitol	SORBITOL	506T60A25R	PASTE / DENTAL	14.6 %w/w		Exact identifier — unii candidate 44 equally ranked IID candidates
Sodium Lauryl Sulfate	SODIUM LAURYL SULFATE	368GB5141J	CREAM / TOPICAL		214 mg	Exact identifier — unii candidate 42 equally ranked IID candidates
Silicon Dioxide	SILICON DIOXIDE	ETJ7Z6XBU4	CREAM / VAGINAL		51 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
Sorbitol	SORBITOL	506T60A25R	SUSPENSION / RECTAL	46.18 %w/v		Exact identifier — unii candidate 44 equally ranked IID candidates
Saccharin Sodium Dihydrate	SACCHARIN SODIUM	SB8ZUX40TY	TABLET, FILM COATED / ORAL	2 mg		Exact identifier — unii candidate 34 equally ranked IID candidates
Sodium Lauryl Sulfate	SODIUM LAURYL SULFATE	368GB5141J	TABLET / SUBLINGUAL	1.1 mg		Exact identifier — unii candidate 42 equally ranked IID candidates
Saccharin Sodium Dihydrate	SACCHARIN SODIUM	SB8ZUX40TY	TABLET / BUCCAL	0.4 mg		Exact identifier — unii candidate 34 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
7375cd98-281b-4ece-bdc5-14ab02eaf788			3579fd94-ee49-4608-94dc-401b66a78ec2	2011-12-29	Warnings	Exact identifier spl id: 7375cd98-281b-4ece-bdc5-14ab02eaf788 spl set id: 3579fd94-ee49-4608-94dc-401b66a78ec2

Reported adverse events (FAERS/openFDA)#

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