Amerfresh Fluoride Geltoothpaste

Amerfresh Fluoride Geltoothpaste
SPL v2
SPL
SPL Set ID 43001122-cc78-48b8-9c10-7d2cfd6a9a2c
Route
DENTAL
Published
Effective Date 2016-09-12
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Fluoride Ion (0.76 g)
Inactive Ingredients
Calcium Carbonate Anhydrous Dibasic Calcium Phosphate Carboxymethylcellulose Glycerin Aluminum Hydroxide Hydrated Silica Potassium Sorbate Sodium Lauryl Sulfate Sorbitan Monooleate Sorbitol Titanium Dioxide Water Xanthan Gum

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2016-09-12
Description

Sodium Monofluorophosphate 0.76%

Purpose

Anticavity toothpaste

Medication Information

Purpose

Anticavity toothpaste

Description

Sodium Monofluorophosphate 0.76%

Use

Aids in the prevention of dental cavities

Section 50565-1

Keep out of reach of children under 6 yrs. of age

Warnings

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

Directions
  • Adults and children 2 yrs. and older: Brush teeth throughtly after meals or at least twice a day or as directed by a dentist.
  • Do not swallow
  • To minimize swallowing, use a pea-sized amount in children under 6 years old.
  • Supervise children's brushing until good habits are established.
  • Children under 2 yrs.: ask a dentist before use.
Active Ingredient

Sodium Monofluorophosphate 0.76%

Inactive Ingredients

SODIUM MONOFLUOROPHOSPHATE, CALCIUM CARBONATE, ANHYDROUS DIBASIC CALCIUM PHOSPHATE, CARBOXYMETHYLCELLULOSE, GLYCERIN, ALUMINUM HYDROXIDE, HYDRATED SILICA, POTASSIUM SORBATE, SODIUM LAURYL SULFATE, SORBITAN MONOOLEATE, SORBITOL, TITANIUM DIOXIDE, WATER, XANTHAN GUM.

Amerfresh Fluoride Gel Toothpaste

Structured Label Content

Use

Aids in the prevention of dental cavities

Section 50565-1 (50565-1)

Keep out of reach of children under 6 yrs. of age

Purpose

Anticavity toothpaste

Warnings

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

Directions
  • Adults and children 2 yrs. and older: Brush teeth throughtly after meals or at least twice a day or as directed by a dentist.
  • Do not swallow
  • To minimize swallowing, use a pea-sized amount in children under 6 years old.
  • Supervise children's brushing until good habits are established.
  • Children under 2 yrs.: ask a dentist before use.
Active Ingredient

Sodium Monofluorophosphate 0.76%

Inactive Ingredients

SODIUM MONOFLUOROPHOSPHATE, CALCIUM CARBONATE, ANHYDROUS DIBASIC CALCIUM PHOSPHATE, CARBOXYMETHYLCELLULOSE, GLYCERIN, ALUMINUM HYDROXIDE, HYDRATED SILICA, POTASSIUM SORBATE, SODIUM LAURYL SULFATE, SORBITAN MONOOLEATE, SORBITOL, TITANIUM DIOXIDE, WATER, XANTHAN GUM.

Amerfresh Fluoride Gel Toothpaste (AmerFresh Fluoride Gel Toothpaste)

Advanced Ingredient Data

Raw Label Data

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Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:56:10.192069 · Updated: 2026-03-14T22:54:26.235755