Dti Stannous - Strawberry

SPL v12

SPL

SPL Set ID 16ebcb37-5703-4e10-b965-570e18434b52

Routes

DENTAL ORAL

Published

Effective Date 2017-08-08

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Fluoride Ion (0.969 mg)

Inactive Ingredients

Ascorbic Acid Anhydrous Citric Acid Glycerin Trolamine Carbomer Homopolymer Type B (allyl Sucrose Crosslinked)

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH DRUG Active Since 1999-12-31

Description

Stannous Fluoride 0.4% (0.12% w/v fluoride ion)

Purpose

Anticavity

Medication Information

Purpose

Anticavity

Description

Stannous Fluoride 0.4% (0.12% w/v fluoride ion)

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.

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%

(0.12% w/v fluoride ion)

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?

1.800.835.0885 or 847.677.5500

Principal Display Panel

alpha-dent®

HOME CARE

FLUORIDE GEL

0.4% STANNOUS FLUORIDE

AIDS IN THE

PREVENTION

OF DENTAL CAVITIES

STRAWBERRY

REF 004.0402.001

NET WEIGHT - 4.3 oz. (121.9g)

DENTAL

TECHNOLOGIES

6901 N HAMLIN AVENUE

LINCOLNWOOD, ILLINOIS 60712 USA

www.dentaltech.com

When Using This Product

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

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.

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 (Active ingredient)

Stannous Fluoride 0.4%

(0.12% w/v fluoride ion)

Other Information (Other information)

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

Inactive Ingredients (Inactive ingredients)

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

Questions Or Comments? (Questions or comments?)

1.800.835.0885 or 847.677.5500

Principal Display Panel

alpha-dent®

HOME CARE

FLUORIDE GEL

0.4% STANNOUS FLUORIDE

AIDS IN THE

PREVENTION

OF DENTAL CAVITIES

STRAWBERRY

REF 004.0402.001

NET WEIGHT - 4.3 oz. (121.9g)

DENTAL

TECHNOLOGIES

6901 N HAMLIN AVENUE

LINCOLNWOOD, ILLINOIS 60712 USA

www.dentaltech.com

When Using This Product (When using this product)

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

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

[{"name": "ASCORBIC ACID", "unii": "PQ6CK8PD0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ANHYDROUS CITRIC ACID", "unii": "XF417D3PSL", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "GLYCERIN", "unii": "PDC6A3C0OX", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "TROLAMINE", "unii": "9O3K93S3TK", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "FLUORIDE ION", "unii": "Q80VPU408O", "classCode": "ACTIM", "strengthNumerator": "0.969", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "g"}, {"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% (0.12% w/v fluoride ion)", "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?": "1.800.835.0885 or 847.677.5500", "Principal Display Panel": "alpha-dent® HOME CARE FLUORIDE GEL 0.4% STANNOUS FLUORIDE AIDS IN THE PREVENTION OF DENTAL CAVITIES STRAWBERRY REF 004.0402.001 NET WEIGHT - 4.3 oz. (121.9g) DENTAL TECHNOLOGIES 6901 N HAMLIN AVENUE LINCOLNWOOD, ILLINOIS 60712 USA www.dentaltech.com", "When using this product": "it may produce surface staining of the teeth. Adequate tooth brushing may prevent these stains which are not harmful or permanent and may be removed by your dentist.", "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."}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:02:46.054541 · Updated: 2026-03-14T23:13:21.652895