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.





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

Section 55106-9

sodium fluoride



Structured Label Content

Indications and Usage (34067-9)

brush with toothbrush and rinse thoroughly





Dosage and Administration (34068-7)

for dental use only



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.





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

Section 55106-9 (55106-9)

sodium fluoride



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