Amerfresh®

Amerfresh®
SPL v1
SPL
SPL Set ID 939919ec-5bd8-4869-8598-b5fcc8fcc08f
Route
DENTAL
Published
Effective Date 2011-03-16
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Fluoride Ion (0.76 g)
Inactive Ingredients
Calcium Carbonate Water Sorbitol 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 TOOTHPASTE

Purpose

Anticavity

Medication Information

Purpose

Anticavity

Description

FLUORIDE TOOTHPASTE

Use

helps protect against cavities.

Section 42229-5

FLUORIDE 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 monofluorophosphate 0.76% (0.1% w/v fluoride ion)

Inactive Ingredients

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

Principal Display Panel 141 G Carton Label

AMERFRESH®

FLUORIDE TOOTHPASTE

NET WT. 5 oz (141g)

Structured Label Content

Use

helps protect against cavities.

Section 42229-5 (42229-5)

FLUORIDE 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 monofluorophosphate 0.76% (0.1% w/v fluoride ion)

Inactive Ingredients

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

Principal Display Panel 141 G Carton Label (PRINCIPAL DISPLAY PANEL - 141 g Carton Label)

AMERFRESH®

FLUORIDE TOOTHPASTE

NET WT. 5 oz (141g)

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:55:13.486741 · Updated: 2026-03-14T22:52:36.393397