Amerfresh®

Amerfresh®
SPL v1
SPL
SPL Set ID bed07ba9-14ed-4dda-9bd9-49dfc5c12129
Route
DENTAL
Published
Effective Date 2011-03-16
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

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

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
OTC MONOGRAPH FINAL Active Since 1996-01-01
Description

FLUORIDE gel TOOTHPASTE

Purpose

Anticavity

Medication Information

Purpose

Anticavity

Description

FLUORIDE gel TOOTHPASTE

Use

helps protect against cavities.

Section 42229-5

FLUORIDE gel TOOTHPASTE

Section 50565-1

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
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.
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.

Principal Display Panel 181 G Carton Label

AMERFRESH®

FLUORIDE gel TOOTHPASTE

NET WT. 6.4 oz (181g)

Structured Label Content

Use

helps protect against cavities.

Section 42229-5 (42229-5)

FLUORIDE gel TOOTHPASTE

Section 50565-1 (50565-1)

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.

Purpose

Anticavity

Directions
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.
Active Ingredient (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.

Principal Display Panel 181 G Carton Label (PRINCIPAL DISPLAY PANEL - 181 g Carton Label)

AMERFRESH®

FLUORIDE gel TOOTHPASTE

NET WT. 6.4 oz (181g)

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:55:13.493589 · Updated: 2026-03-14T22:52:36.393397