Amerfresh Fluoride Toothpaste

Amerfresh Fluoride Toothpaste
SPL v7
SPL
SPL Set ID ff4d62a9-2f0b-495f-aa52-9030193d7148
Route
DENTAL
Published
Effective Date 2018-04-20
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Fluoride Ion (0.1 g)
Inactive Ingredients
Potassium Sodium Saccharate Calcium Carbonate Methylisothiazolinone Hydrated Silica Sodium Lauryl Sulfate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2018-04-20
Description

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

Purpose

anticavity

Medication Information

Purpose

anticavity

Description

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

Uses

aids in the prevention of dental cavities.

Section 50565-1

Keep out of reach of children.

Section 51945-4

Warnings

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

For Use:

  • Wet toothbrush and dip into powder until brush is fully covered
  • do not swallow .
  • supervise children as necessary until capable of useing 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 physician.
  • Children under 6 years of age:do not use unless directed by a doctor or dentist.
Active Ingredients

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

Inactive Ingredient

calcium carbonate, silica,sodium lauryl sulfate, flavor, sodium sacharine, methylisothiazolinone

Structured Label Content

Uses

aids in the prevention of dental cavities.

Section 50565-1 (50565-1)

Keep out of reach of children.

Section 51945-4 (51945-4)

Purpose

anticavity

Warnings

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

For Use:

  • Wet toothbrush and dip into powder until brush is fully covered
  • do not swallow .
  • supervise children as necessary until capable of useing 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 physician.
  • Children under 6 years of age:do not use unless directed by a doctor or dentist.
Active Ingredients (Active ingredients)

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

Inactive Ingredient (INACTIVE INGREDIENT)

calcium carbonate, silica,sodium lauryl sulfate, flavor, sodium sacharine, methylisothiazolinone

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:04:51.301814 · Updated: 2026-03-14T23:05:56.026643