85162-007, amerfresh fluoride toothpowder

85162-007, amerfresh fluoride toothpowder
SPL v2
SPL
SPL Set ID 1cacf93e-aa60-4717-87ab-0568a701a4f3
Route
topical
Published
Effective Date 2025-08-13
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
fluoride ion (0.1 g)
Inactive Ingredients
sodium saccharin calcium carbonate hydrated silica sodium lauryl sulfate methylparaben propylparaben

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2025-08-13
Purpose

Anticavity toothpaste

Description

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

Medication Information

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.

Uses

aids in the prevention of dental cavities.

Purpose

Anticavity toothpaste

Directions

For Use:

  • Wet toothbrush and dip into powder until brush is fully covered. 
  • Brush teeth and gum line for tleast 30 seconds, rinse and spit out thoroughly
  • 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.
Description

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

Section 50565-1

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

Section 51945-4

Active Ingredients

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

Inactive Ingredient

Calcium carbonate, Silica, Sodium Lauryl Sulfate, Flavor, Sodium Saccharin, Methylparaben, Propylparaben

Structured Label Content

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.

Uses

aids in the prevention of dental cavities.

Purpose

Anticavity toothpaste

Directions

For Use:

  • Wet toothbrush and dip into powder until brush is fully covered. 
  • Brush teeth and gum line for tleast 30 seconds, rinse and spit out thoroughly
  • 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.
Section 50565-1 (50565-1)

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

Section 51945-4 (51945-4)

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 Saccharin, Methylparaben, Propylparaben

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

Back to search View SPL set listing Open on DailyMed ↗

Source: dailymed · Ingested: 2026-02-15T12:06:45.469469 · Updated: 2026-03-14T23:14:10.164520