plaque hd anticavity toothpaste fresh mint flavor

plaque hd anticavity toothpaste fresh mint flavor
SPL v17
SPL
SPL Set ID 98d07260-5274-42b7-bbf8-9683c5e8b624
Route
dental
Published
Effective Date 2016-03-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
fluoride ion (0.14 g)
Inactive Ingredients
water sorbitol hydrated silica glycerin sodium pyrophosphate sodium bicarbonate povidone, unspecified sodium benzoate sodium lauryl sulfate carbomer homopolymer, unspecified type carboxymethylcellulose sodium, unspecified annatto xylitol saccharin sodium edetate disodium fd&c blue no. 1

Identifiers & Packaging

Marketing Status
otc monograph drug completed Since 2013-06-10 Until 2026-03-21
Purpose

Anticavity

Description

Sodium Fluoride 0.24% (0.14% w/v Fluoride Ion)

Medication Information

Warnings

Purpose

Anticavity

Directions
  • Adults and children 2 years of age or older: Brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a doctor. Instruct children under 6 years of age in good brushing and rinsing habits (to minimize swallowing). Supervise children as necessary until capable of using without supervision.
  • Children under 2 year of age: Consult a dentist or doctor
Other Information
  • Store at room temperature
Inactive Ingredients

Water, sorbitol, hydrated silica, glycerin, tetrasodium pyrophsphate, sodium bicarbonate, PVP, sodium benzoate, sodium lauryl sulfate, flavor, carbomer, cellulose gum, annatto extract, xylitol, sodium saccharin, disodium EDTA, blue 1.

Description

Sodium Fluoride 0.24% (0.14% w/v Fluoride Ion)

Questions?

call toll-free-1-(800) 737-4860

Use

Aids in the prevention of dental cavities.

Drug Facts

Active Ingredient

Sodium Fluoride 0.24% (0.14% w/v Fluoride Ion)

Keep Out of Reach of Children

under 6 years of age. If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

Package Labeling: 57660 000 01

Representative Labeling (57660 000 03)

Structured Label Content

Warnings

Purpose

Anticavity

Directions
  • Adults and children 2 years of age or older: Brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a doctor. Instruct children under 6 years of age in good brushing and rinsing habits (to minimize swallowing). Supervise children as necessary until capable of using without supervision.
  • Children under 2 year of age: Consult a dentist or doctor
Other Information (Other information)
  • Store at room temperature
Inactive Ingredients (Inactive ingredients)

Water, sorbitol, hydrated silica, glycerin, tetrasodium pyrophsphate, sodium bicarbonate, PVP, sodium benzoate, sodium lauryl sulfate, flavor, carbomer, cellulose gum, annatto extract, xylitol, sodium saccharin, disodium EDTA, blue 1.

Questions?

call toll-free-1-(800) 737-4860

Use

Aids in the prevention of dental cavities.

Drug Facts

Active Ingredient

Sodium Fluoride 0.24% (0.14% w/v Fluoride Ion)

Keep Out of Reach of Children (Keep out of reach of children)

under 6 years of age. If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

Package Labeling: 57660 000 01 (Package Labeling: 57660-000-01)

Representative Labeling (57660 000 03) (Representative Labeling (57660-000-03))

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:06:12.227587 · Updated: 2026-03-14T23:08:50.768383