Amerfresh®

Amerfresh®
SPL v3
SPL
SPL Set ID 018990a8-bcc7-43f9-928e-db937f5705bc
Route
ORAL
Published
Effective Date 2015-01-22
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Fluoride Ion (1 mg)
Inactive Ingredients
Calcium Carbonate Water Sorbitol 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 6 years of age: Do not use unless directed by a doctor or dentist
Active Ingredient

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

Inactive Ingredients

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

Principal Display Panel 85 G Tube Label Ndc 51460 1112

AMERFRESH ®

FLUORIDE TOOTHPASTE NET WT. 3 oz (85g)

Principal Display Panel 85 G Tube Label Ndc 51460 1114

AMERFRESH ®

FLUORIDE 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 6 years of age: Do not use unless directed by a doctor or dentist
Active Ingredient (Active ingredient)

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

Inactive Ingredients (Inactive ingredients)

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

Principal Display Panel 85 G Tube Label Ndc 51460 1112 (PRINCIPAL DISPLAY PANEL - 85 g Tube Label - NDC 51460-1112)

AMERFRESH ®

FLUORIDE TOOTHPASTE NET WT. 3 oz (85g)

Principal Display Panel 85 G Tube Label Ndc 51460 1114 (PRINCIPAL DISPLAY PANEL - 85 g Tube Label - NDC 51460-1114)

AMERFRESH ®

FLUORIDE TOOTHPASTE NET WT. 3 oz (85g)

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:55:53.579664 · Updated: 2026-03-14T22:53:56.080797