plak smacker stannous gel - bubble gum

SPL v3

SPL

SPL Set ID e65c62d9-e8a6-3101-e053-2995a90a1494

Routes

dental oral

Published

Effective Date 2022-08-16

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

fluoride ion (0.969 mg)

Inactive Ingredients

glycerin ascorbic acid trolamine anhydrous citric acid carbomer homopolymer type b (allyl sucrose crosslinked)

Identifiers & Packaging

Marketing Status

otc monograph drug active Since 2007-12-31

Purpose

Anticavity

Description

Stannous Fluoride 0.4%

Medication Information

Warnings

This is an anticavity fluoride preventive treatment gel, not a toothpaste. Read directions carefully before using.

Uses

Helps aid in the prevention of dental cavities.

Purpose

Anticavity

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.

Other Information

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

Inactive Ingredients

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

Description

Stannous Fluoride 0.4%

Principal Display Panel

Home Care

Fluoride Gel

0.4% Stannous Fluoride

Bubblegum

Burst

11422

AIDS IN THE

PREVENTION

OF DENTAL CAVITIES

PLAK

SMACKER

Net Weight 4.3 oz (121.9 g)

Active Ingredient

Stannous Fluoride 0.4%

Questions Or Comments?

1-800-558-6684

Structured Label Content

Warnings

This is an anticavity fluoride preventive treatment gel, not a toothpaste. Read directions carefully before using.

Uses

Helps aid in the prevention of dental cavities.

Purpose

Anticavity

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.

Other Information (Other information)

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

Inactive Ingredients (Inactive ingredients)

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

Principal Display Panel

Home Care

Fluoride Gel

0.4% Stannous Fluoride

Bubblegum

Burst

11422

AIDS IN THE

PREVENTION

OF DENTAL CAVITIES

PLAK

SMACKER

Net Weight 4.3 oz (121.9 g)

Active Ingredient (Active ingredient)

Stannous Fluoride 0.4%

Questions Or Comments? (Questions or comments?)

1-800-558-6684

Advanced Ingredient Data

[{"name": "FLUORIDE ION", "unii": "Q80VPU408O", "classCode": "ACTIM", "strengthNumerator": "0.969", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "g"}, {"name": "GLYCERIN", "unii": "PDC6A3C0OX", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ASCORBIC ACID", "unii": "PQ6CK8PD0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "TROLAMINE", "unii": "9O3K93S3TK", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ANHYDROUS CITRIC ACID", "unii": "XF417D3PSL", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CARBOMER HOMOPOLYMER TYPE B (ALLYL SUCROSE CROSSLINKED)", "unii": "Z135WT9208", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"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.", "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 of 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 Bubblegum Burst 11422 AIDS IN THE PREVENTION OF DENTAL CAVITIES PLAK SMACKER Net Weight 4.3 oz (121.9 g)"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:02:46.102012 · Updated: 2026-03-14T23:13:25.872506