70766-008

70766-008
SPL v3
SPL
SPL Set ID 11c712ee-638f-4539-b73a-2f997f433ed4
Route
TOPICAL
Published
Effective Date 2022-02-28
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Fluoride Ion (0.1 g)
Inactive Ingredients
Saccharin Sodium Sorbitol Glycerin Hydrated Silica Sodium Lauryl Sulfate Xanthan Gum Water Sodium Benzoate Cetylpyridinium Chloride

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2022-02-28
Description

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

Purpose

anticavity toothpaste

Medication Information

Purpose

anticavity toothpaste

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
  • 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

Sorbitol, Hydrated Silica, Water, PEG-8, Sodium Lauryl Sulfate, Cellulose Gum, Flavor, Sodium Saccharin, Glycerin, anthan Gum, Sodium Benzoate, Cetylpyridinium Chloride.    

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 toothpaste

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
  • 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)

Sorbitol, Hydrated Silica, Water, PEG-8, Sodium Lauryl Sulfate, Cellulose Gum, Flavor, Sodium Saccharin, Glycerin, anthan Gum, Sodium Benzoate, Cetylpyridinium Chloride.    

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

Back to search View SPL set listing Open on DailyMed ↗

Source: dailymed · Ingested: 2026-02-15T12:04:50.624290 · Updated: 2026-03-14T23:05:54.616139