Drug Facts

Drug Facts
SPL v4
SPL
SPL Set ID e9145a59-c7b4-48ac-e053-2a95a90a0bb3
Route
DENTAL
Published
Effective Date 2022-10-19
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Fluoride Ion (0.02 g)
Inactive Ingredients
Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2022-07-03

Description

sodium fluoride


Medication Information

Warnings and Precautions

Be careful not to swallow it, and rinse your mouth thoroughly after use.

Indications and Usage

1. Put one cup in mouth.

2. Gargle for 30 sec ~ 1 minute

3. Spit it out.

5. Rinse with water.

Dosage and Administration

dental use only

Description

sodium fluoride

Section 50565-1

KEEP OUT OF REACH OF THE CHILDREN

Section 51727-6

menthol

xylitol

Sodium acetate

Allanine

Acetic acid

Propolis

Chitosan

Green tea extract

Stevia

Cyclodextrin

Benzoic acid

Red ginsengs extract

Caramel

Grapefruit seed extract

Maple flavor

Rooibos tea flavor

Purified Water

Section 51945-4

Section 55105-1

dental care

Section 55106-9

sodium fluoride


Structured Label Content

Indications and Usage (34067-9)

1. Put one cup in mouth.

2. Gargle for 30 sec ~ 1 minute

3. Spit it out.

5. Rinse with water.

Dosage and Administration (34068-7)

dental use only

Warnings and Precautions (34071-1)

Be careful not to swallow it, and rinse your mouth thoroughly after use.

Section 50565-1 (50565-1)

KEEP OUT OF REACH OF THE CHILDREN

Section 51727-6 (51727-6)

menthol

xylitol

Sodium acetate

Allanine

Acetic acid

Propolis

Chitosan

Green tea extract

Stevia

Cyclodextrin

Benzoic acid

Red ginsengs extract

Caramel

Grapefruit seed extract

Maple flavor

Rooibos tea flavor

Purified Water

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

dental care

Section 55106-9 (55106-9)

sodium fluoride


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)