b41b4d44-b048-4171-93c1-2446c655d7f3

SPL v2
SPL
SPL Set ID b41b4d44-b048-4171-93c1-2446c655d7f3
Route
oral
Published
Effective Date 2010-01-18
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
fluoride ion (1.4 g) silicon dioxide (14 g) glycerin (5 g)

Identifiers & Packaging

Marketing Status
otc monograph final active Since 2010-01-20
Description

Active Ingredients: Colloidal Silicon Dioxide, Sodium Monofluorophosphate, Sodium Chloride, Glycerin

Medication Information

Warnings and Precautions
Warnings: When using this product, do not use for sensitivity longer than four weeks unless recommended by a dentist.  Stop use and ask a dentist if the sensitivity problem persists or worsens.  Sensitive tooth may indicate a serious problem that may need prompt care.

Active Ingredient
Active Ingredients: Colloidal Silicon Dioxide, Sodium Monofluorophosphate, Sodium Chloride, Glycerin

Description

Active Ingredients: Colloidal Silicon Dioxide, Sodium Monofluorophosphate, Sodium Chloride, Glycerin

Section 50565-1
Keep out of reach of children.  If accidentally swallowed, get medical help or contact a Poison Control Center right away.

Section 50567-7
Direction: adults and children 12 yrs and older.  apply at least a half-inch strip of the product onto a soft bristled toothbrush.  Brush teeth thoroughly for at least 3 minutes twice a day (morning and evening).  under 12 yrs ask a dentist.

Section 51727-6
Inactive Ingredients: D-Sorbitol Solution, Polyethylene Glycol 1500, Hydrated Silica, Carboxymethylcellulose Sodium, Chitosan, Sodium Alginate, Tocopherol Acetate, Xylitol, Saccharin Sodium, Methyl Parahydroxybenzoate, Sodium Lauryl Sulfate, Argentum, Mentha Oil, L-Menthol, Purified Water

Section 51945-4

Structured Label Content

Warnings and Precautions (34071-1)
Warnings: When using this product, do not use for sensitivity longer than four weeks unless recommended by a dentist.  Stop use and ask a dentist if the sensitivity problem persists or worsens.  Sensitive tooth may indicate a serious problem that may need prompt care.

Active Ingredient (55106-9)
Active Ingredients: Colloidal Silicon Dioxide, Sodium Monofluorophosphate, Sodium Chloride, Glycerin

Section 50565-1 (50565-1)
Keep out of reach of children.  If accidentally swallowed, get medical help or contact a Poison Control Center right away.

Section 50567-7 (50567-7)
Direction: adults and children 12 yrs and older.  apply at least a half-inch strip of the product onto a soft bristled toothbrush.  Brush teeth thoroughly for at least 3 minutes twice a day (morning and evening).  under 12 yrs ask a dentist.

Section 51727-6 (51727-6)
Inactive Ingredients: D-Sorbitol Solution, Polyethylene Glycol 1500, Hydrated Silica, Carboxymethylcellulose Sodium, Chitosan, Sodium Alginate, Tocopherol Acetate, Xylitol, Saccharin Sodium, Methyl Parahydroxybenzoate, Sodium Lauryl Sulfate, Argentum, Mentha Oil, L-Menthol, Purified Water

Section 51945-4 (51945-4)

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:54:59.396102 · Updated: 2026-03-14T22:52:15.877958