85162-001

85162-001
SPL v1
SPL
SPL Set ID 86279b4d-82e5-45b5-9ba7-94fe3620b850
Route
TOPICAL
Published
Effective Date 2025-01-16
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 2025-01-16
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

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Source: dailymed · Ingested: 2026-02-15T12:05:22.094841 · Updated: 2026-03-14T23:07:03.829205