Amerfresh®

Amerfresh®
SPL v1
SPL
SPL Set ID 1e09d9ed-b8e2-4998-845b-93ed861542be
Route
DENTAL
Published
Effective Date 2011-05-12
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Fluoride Ion (0.76 g)
Inactive Ingredients
Calcium Carbonate Carboxymethylcellulose Sodium Saccharin Sodium Sodium Lauryl Sulfate Methylparaben Sodium Propylparaben Sodium Silicon Dioxide Ponceau 4r

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 1996-01-01
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.

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

Calcium Carbonate, Sodium Carboxy Methyl Cellulose, Sodium Saccharin, Sodium Lauryl Sulfate, Flavour, Silica, Methyl Paraben Sodium, Propyl Paraben Sodium and Cl 16255 Q.S.

Principal Display Panel 446 G Carton

AMERFRESH ®

FLUORIDE TOOTHPOWDER

NET WEIGHT 1 lb (446 g)

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.

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

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

Inactive Ingredients

Calcium Carbonate, Sodium Carboxy Methyl Cellulose, Sodium Saccharin, Sodium Lauryl Sulfate, Flavour, Silica, Methyl Paraben Sodium, Propyl Paraben Sodium and Cl 16255 Q.S.

Principal Display Panel 446 G Carton (PRINCIPAL DISPLAY PANEL - 446 g Carton)

AMERFRESH ®

FLUORIDE TOOTHPOWDER

NET WEIGHT 1 lb (446 g)

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:55:15.509921 · Updated: 2026-03-14T22:52:39.796827