drug facts

drug facts
SPL v1
SPL
SPL Set ID ceec3fd2-f7b5-4e64-a4d8-b95123202b39
Route
dental
Published
Effective Date 2013-05-02
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
fluoride ion (0.001 mg)
Inactive Ingredients
allantoin xylitol green tea leaf sage chamomile grapefruit

Identifiers & Packaging

Marketing Status
otc monograph final active Since 2013-05-02
Description

sodium fluoride

Medication Information

Warnings and Precautions

- Children under the age of 6 should be accompanied by an adult when using this product and should use no more than a pea-sized amount. If over consumption occurs, please contact a qualified medical professional immediately.

- Avoid sucking or swallowing.

- For oral hygiene purposes only.

- If any side effects occur, please contact a qualified medical or dental professional immediately.





Active Ingredient

sodium fluoride



Indications and Usage

brush with toothbrush and rinse thoroughly





Dosage and Administration

for dental use only



Description

sodium fluoride

Section 50565-1

keep out of reach of the children



Section 51727-6

allantoin, xylitol, greentea extract, sage extract, chamomile extract, grapefruit seed extract



Section 51945-4
Section 55105-1

Clean and maintain the aesthetics and health of teeth including but not warranted to the prevention of gingival and periodontal disease

Structured Label Content

Warnings and Precautions (34071-1)

- Children under the age of 6 should be accompanied by an adult when using this product and should use no more than a pea-sized amount. If over consumption occurs, please contact a qualified medical professional immediately.

- Avoid sucking or swallowing.

- For oral hygiene purposes only.

- If any side effects occur, please contact a qualified medical or dental professional immediately.





Active Ingredient (55106-9)

sodium fluoride



Indications and Usage (34067-9)

brush with toothbrush and rinse thoroughly





Dosage and Administration (34068-7)

for dental use only



Section 50565-1 (50565-1)

keep out of reach of the children



Section 51727-6 (51727-6)

allantoin, xylitol, greentea extract, sage extract, chamomile extract, grapefruit seed extract



Section 51945-4 (51945-4)
Section 55105-1 (55105-1)

Clean and maintain the aesthetics and health of teeth including but not warranted to the prevention of gingival and periodontal disease

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:55:37.768052 · Updated: 2026-03-14T22:53:29.712463