Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID 69fa139f-e50f-498f-9aea-a2bb2c5a52bf
Route
DENTAL
Published
Effective Date 2011-08-25
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Fluoride Ion (2.2 mg)
Inactive Ingredients
Water Sorbitol Hydrated Silica Sodium Methyl Cocoyl Taurate Peg-32 Stearate Sodium Lauryl Sulfate Sodium Chloride Croscarmellose Sodium Saccharin Sodium Sodium Phosphate, Dibasic Menthol Methylparaben Pinus Strobus Bark

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2011-08-22
Description

sodium fluoride 0.22%

Purpose

Anticavity

Medication Information

Purpose
Anticavity
Description

sodium fluoride 0.22%

Uses
helps protect against cavities

Warnings

Enter section text here

Directions
Adults and children 2 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 physician
Children 2 to 6 years

 use only a pea sized amount and supervise child's brushing and rinsing (to minimize swallowing).
Children under 2 years

 ask a dentist or physician
Package Label

Pine Salt Toothpaste

Active Ingredient
sodium fluoride 0.22%

Inactive Ingredients
di water, sorbitol, hydrated silica, sodium methyl cocoyl taurate, peg-32, sodium lauryl sulfate, baked sodium chloride, flavor, cellulose gum, songyum capsule, sodium saccharin, disodium phosphate, menthol capsule, methyl paraben, pine extract, tranexamic acid, yellow no.10, blue no.1

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.

Structured Label Content

Uses
helps protect against cavities

Purpose
Anticavity
Warnings

Enter section text here

Directions
Adults and children 2 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 physician
Children 2 to 6 years

 use only a pea sized amount and supervise child's brushing and rinsing (to minimize swallowing).
Children under 2 years

 ask a dentist or physician
Package Label (Package label)

Pine Salt Toothpaste

Active Ingredient (Active ingredient)
sodium fluoride 0.22%

Inactive Ingredients (Inactive ingredients)
di water, sorbitol, hydrated silica, sodium methyl cocoyl taurate, peg-32, sodium lauryl sulfate, baked sodium chloride, flavor, cellulose gum, songyum capsule, sodium saccharin, disodium phosphate, menthol capsule, methyl paraben, pine extract, tranexamic acid, yellow no.10, blue no.1

Keep Out of Reach of Children Under 6 Years of Age. (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.

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:55:19.567118 · Updated: 2026-03-14T22:52:49.153069