Drug Facts

Drug Facts
SPL v4
SPL
SPL Set ID e6ffe0e7-396b-4206-861f-2f1d6de0b35d
Routes
DENTAL ORAL
Published
Effective Date 2015-10-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Fluoride Ion (0.969 mg)
Inactive Ingredients
Ascorbic Acid Carbomer 934 Anhydrous Citric Acid Glycerin Trolamine

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2007-12-31
Description

Stannous Fluoride 0.4%

Purpose

Anticavity

Medication Information

Purpose

Anticavity

Description

Stannous Fluoride 0.4%

Uses

Helps aid in the prevention of dental cavities.

Warnings:

This is an anticavity fluoride preventive treatment gel, not a toothpaste.

Read directions carefully before using.

When using this product it may produce surface staining of the teeth. Adequate tooth brushing may prevent these stains which are not harmful to permanent and may be removed by your dentist.

Directions:
  • Adults and children 6 years of age and older: Use once a day after brushing your teeth with a toothpaste. Apply the gel to your teeth and brush thoroughly. Allow the gel to remain on your teeth for 1 minute and then spit out. Do not swallow the gel. Do not eat or drink for 30 minutes after brushing.
  • Instruct children under 12 years of age in the use of this product (to minimize swallowing). Supervise children as necessary until capable of using without supervision.
  • Children under 6 years of age: Consult a dentist or doctor.

Active Ingredient

Stannous Fluoride 0.4%

Other Information

Do not use if the foil seal under the cap is torn, cut or missing.

Inactive Ingredients:

Ascorbic Acid, Carbomer, Citric Acid, Flavor, Glycerin, Triethanolamine

Questions Or Comments?

1-800-558-6684

Principal Display Panel

HOME CARE

FLUORIDE GEL

0.4% STANNOUS FLUORIDE

Mouth-Watering Watermelon

11425

AIDS IN THE

PREVENTION

OF DENTAL CAVITIES

PLAK SMACKER

NET WEIGHT - 4.3 oz. (121.9g)

Keep Out of Reach of Children.

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 aid in the prevention of dental cavities.

Purpose

Anticavity

Warnings:

This is an anticavity fluoride preventive treatment gel, not a toothpaste.

Read directions carefully before using.

When using this product it may produce surface staining of the teeth. Adequate tooth brushing may prevent these stains which are not harmful to permanent and may be removed by your dentist.

Directions:
  • Adults and children 6 years of age and older: Use once a day after brushing your teeth with a toothpaste. Apply the gel to your teeth and brush thoroughly. Allow the gel to remain on your teeth for 1 minute and then spit out. Do not swallow the gel. Do not eat or drink for 30 minutes after brushing.
  • Instruct children under 12 years of age in the use of this product (to minimize swallowing). Supervise children as necessary until capable of using without supervision.
  • Children under 6 years of age: Consult a dentist or doctor.

Active Ingredient

Stannous Fluoride 0.4%

Other Information

Do not use if the foil seal under the cap is torn, cut or missing.

Inactive Ingredients:

Ascorbic Acid, Carbomer, Citric Acid, Flavor, Glycerin, Triethanolamine

Questions Or Comments? (Questions or comments?)

1-800-558-6684

Principal Display Panel

HOME CARE

FLUORIDE GEL

0.4% STANNOUS FLUORIDE

Mouth-Watering Watermelon

11425

AIDS IN THE

PREVENTION

OF DENTAL CAVITIES

PLAK SMACKER

NET WEIGHT - 4.3 oz. (121.9g)

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

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: 2026-02-15T11:56:01.407398 · Updated: 2026-03-14T22:54:11.557814