THE GARGLE- sodium fluoride mouthwash

The Gargle by

Drug Labeling and Warnings

The Gargle by is a Otc medication manufactured, distributed, or labeled by PBS Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

sodium fluoride

INACTIVE INGREDIENT

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, caramel color

PURPOSE

for dental care

KEEP OUT OF REACH OF CHILDREN

keep out of reach of the children

INDICATIONS & 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

WARNINGS

do not swallow

DOSAGE & ADMINISTRATION

for oral administration

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

THE GARGLE 
sodium fluoride mouthwash

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 41525-5001
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	0.02 mg  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
ALLANTOIN (UNII: 344S277G0Z)
SODIUM BENZOATE (UNII: OJ245FE5EU)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 41525-5001-2	10 in 1 PACKAGE
1	NDC: 41525-5001-1	11 mL in 1 POUCH
2	NDC: 41525-5001-3	250 mL in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part355	09/11/2014

Labeler - PBS Co., Ltd. (690329669)

Registrant - PBS Co., Ltd. (690329669)

Establishment
Name	Address	ID/FEI	Business Operations
PBS Co., Ltd.		690329669	manufacture(41525-5001)