Drug Facts

Drug Facts
SPL v2
SPL
SPL Set ID 1554b1b5-1ad8-a3f8-e063-6294a90a06e9
Route
DENTAL
Published
Effective Date 2023-10-05
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Fluoride Ion (0.05 g)
Inactive Ingredients
Xylitol Panax Ginseng Root Oil Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-10-05

Description

sodium fluoride


Medication Information

Warnings and Precautions

if more than used for rinsing is accidentally swallowed, get medical help or contact a Poison Control Center right away

Indications and Usage

Adult and over 12 years old

¡ Use twice a day after brushing your teeth with a toothpaste

¡ 30 seconds vigorously swish contents of one packet and spit out

¡ Do not swallow after rinsed

¡ Recommend do not eat or drink for 30 minutes after rinsed. It will be better results

¡ Supervise children as necessary until capable of suing withour supervision

¡ Consult with doctor or dentist before use if you have any injuries such as dental works in your mouth

Dosage and Administration

for dental use only

Description

sodium fluoride

Section 50565-1

KEEP OUT OF REACH OF THE CHILDREN

Section 51727-6

Glycerin, Xylitol, DL-Alanine, Stevia, Sea Salt, Green tea Extract., Chitosan, Ginger tincture, Licorice Extract, Panax Ginseng Root Extract, Centella Extract, Acetic acid, Sodium citrate, Citric Acid, Tea Tree Oil, Peppermint Oil, Eucalyptol, Shine Muscat Flavor Sorbic acid, Sodium carboxymethylcellulose, L-menthol, Purified water

Section 51945-4

Section 55105-1

Anticavity

Section 55106-9

sodium fluoride


Structured Label Content

Indications and Usage (34067-9)

Adult and over 12 years old

¡ Use twice a day after brushing your teeth with a toothpaste

¡ 30 seconds vigorously swish contents of one packet and spit out

¡ Do not swallow after rinsed

¡ Recommend do not eat or drink for 30 minutes after rinsed. It will be better results

¡ Supervise children as necessary until capable of suing withour supervision

¡ Consult with doctor or dentist before use if you have any injuries such as dental works in your mouth

Dosage and Administration (34068-7)

for dental use only

Warnings and Precautions (34071-1)

if more than used for rinsing is accidentally swallowed, get medical help or contact a Poison Control Center right away

Section 50565-1 (50565-1)

KEEP OUT OF REACH OF THE CHILDREN

Section 51727-6 (51727-6)

Glycerin, Xylitol, DL-Alanine, Stevia, Sea Salt, Green tea Extract., Chitosan, Ginger tincture, Licorice Extract, Panax Ginseng Root Extract, Centella Extract, Acetic acid, Sodium citrate, Citric Acid, Tea Tree Oil, Peppermint Oil, Eucalyptol, Shine Muscat Flavor Sorbic acid, Sodium carboxymethylcellulose, L-menthol, Purified water

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Anticavity

Section 55106-9 (55106-9)

sodium fluoride


Advanced Ingredient Data


Raw Label Data

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