Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID 03042aa5-fb3b-4057-855b-84b7237eaeb1
Route
DENTAL
Published
Effective Date 2015-01-22
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Fluoride Ion (0.02 mg)
Inactive Ingredients
Allantoin Xylitol Citric Acid Monohydrate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2015-01-22
Description

sodium fluoride

Medication Information

Warnings and Precautions

do not swallow



Indications and Usage

① Turn the container cap and open, pour The Gargle into the cap about 10-15ml (not to overflow the cap) and

put into mouth.

② Goggle it thoroughly all over the inner mouth about 10 seconds.

③ After ②, in order to sterilize mouth, hold the liquid in the mouth about 30 seconds and spit out



Dosage and Administration

for oral administration



Description

sodium fluoride

Section 50565-1

keep out of reach of the children



Section 51727-6

purified water, ethyl alcohol, allantoin, glycerin, xylitol, sodium saccharin, green tea, malic acid, lactic acid, sodium benzoate, citric acid peg-40 hydrogenated castor oil, sodium citrate, l-menthol, red ginseng ext, ulmus ext, red ginseng fragrance, mint fragrance, houttuynia ext, propolis ext



Section 51945-4
Section 55105-1

for dental care



Section 55106-9

sodium fluoride



Structured Label Content

Indications and Usage (34067-9)

① Turn the container cap and open, pour The Gargle into the cap about 10-15ml (not to overflow the cap) and

put into mouth.

② Goggle it thoroughly all over the inner mouth about 10 seconds.

③ After ②, in order to sterilize mouth, hold the liquid in the mouth about 30 seconds and spit out



Dosage and Administration (34068-7)

for oral administration



Warnings and Precautions (34071-1)

do not swallow



Section 50565-1 (50565-1)

keep out of reach of the children



Section 51727-6 (51727-6)

purified water, ethyl alcohol, allantoin, glycerin, xylitol, sodium saccharin, green tea, malic acid, lactic acid, sodium benzoate, citric acid peg-40 hydrogenated castor oil, sodium citrate, l-menthol, red ginseng ext, ulmus ext, red ginseng fragrance, mint fragrance, houttuynia ext, propolis ext



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

for dental care



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: 2026-02-15T11:55:53.558146 · Updated: 2026-03-14T22:53:56.080797