Charm-tex

Charm-tex
SPL v1
SPL
SPL Set ID 3579fd94-ee49-4608-94dc-401b66a78ec2
Route
DENTAL
Published
Effective Date 2011-12-29
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Fluoride Ion (0.22 g)
Inactive Ingredients
Sorbitol Silicon Dioxide Sodium Lauryl Sulfate Carboxymethylcellulose Sodium Saccharin Sodium Dihydrate Methylparaben Sodium Propylparaben Sodium

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2011-06-01
Description

DRUG FACTS

Purpose

Anticavity

Medication Information

Purpose

Anticavity

Description

DRUG FACTS

Use

helps protect against cavities.

Section 42229-5

DRUG FACTS

Section 50565-1

Keep out of the reach of children under 6 years of age.

Section 50567-7

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

Active Ingredient

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

Inactive Ingredient

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

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.

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.

Principal Display Panel 42.5 Grams Tube Label

Charm-Tex

FLUORIDE GEL TOOTHPASTE

Net Wt. 1.5 oz.

42.5 Grams

Structured Label Content

Use

helps protect against cavities.

Section 42229-5 (42229-5)

DRUG FACTS

Section 50565-1 (50565-1)

Keep out of the reach of children under 6 years of age.

Section 50567-7 (50567-7)

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

Purpose

Anticavity

Active Ingredient (Active ingredient)

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

Inactive Ingredient (Inactive ingredient)

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

Children 2 to 6 Years (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 (Children under 2 years)

Ask a dentist or physician.

Adults and Children 6 Years of Age and Older (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.

Principal Display Panel 42.5 Grams Tube Label (PRINCIPAL DISPLAY PANEL - 42.5 Grams Tube Label)

Charm-Tex

FLUORIDE GEL TOOTHPASTE

Net Wt. 1.5 oz.

42.5 Grams

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:55:23.777278 · Updated: 2026-03-14T22:52:57.217022