Amerfresh®

Amerfresh®
SPL v1
SPL
SPL Set ID 7d12eab2-ad71-4743-9c47-2f3b3bc2aa81
Route
ORAL
Published
Effective Date 2012-11-07
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Fluoride Ion (0.187 g)
Inactive Ingredients
Sorbitol Water Hydrated Silica Sodium Lauryl Sulfate Carboxymethylcellulose Sodium Saccharin Sodium Methylparaben Sodium Propylparaben Sodium

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
OTC MONOGRAPH FINAL Active Since 2012-11-14
Description

Drug Facts

Purpose

Anticavity toothpaste

Medication Information

Purpose

Anticavity toothpaste

Description

Drug Facts

Use

aids in the prevention of dental 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
  • do not swallow
  • supervise children as necessary until capable of using without supervision
  • Instruct children under 12 years of age in good brushing and rinsing habits (to minimize swallowing).
  • 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 doctor.
  • Children under 2 years of age: Consult a dentist or doctor
Active Ingredient

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

Inactive Ingredients

sorbitol, water, hydrated silica, sodium lauryl sulfate, sodium carboxymethyl cellulose, flavor, sodium saccharine, sodium methyl paraben, sodium propyl Paraben.

Principal Display Panel 85g Tube Label

AMERFRESH ®

FLUORIDE Gel TOOTHPASTE

NET WT. 3 oz (85g)

Structured Label Content

Use

aids in the prevention of dental 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 toothpaste

Directions
  • do not swallow
  • supervise children as necessary until capable of using without supervision
  • Instruct children under 12 years of age in good brushing and rinsing habits (to minimize swallowing).
  • 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 doctor.
  • Children under 2 years of age: Consult a dentist or doctor
Active Ingredient (Active ingredient)

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

Inactive Ingredients (Inactive ingredients)

sorbitol, water, hydrated silica, sodium lauryl sulfate, sodium carboxymethyl cellulose, flavor, sodium saccharine, sodium methyl paraben, sodium propyl Paraben.

Principal Display Panel 85g Tube Label (PRINCIPAL DISPLAY PANEL - 85g Tube Label)

AMERFRESH ®

FLUORIDE Gel TOOTHPASTE

NET WT. 3 oz (85g)

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

Back to search View SPL set listing Open on DailyMed ↗

Source: dailymed · Ingested: 2026-02-15T11:55:33.642276 · Updated: 2026-03-14T22:53:20.556394