SOONSOO GARGLE- sodium fluoride mouthwash

SoonSoo gargle by

Drug Labeling and Warnings

SoonSoo gargle by is a Otc medication manufactured, distributed, or labeled by Chang Hwa Dang Co., Ltd., ECOWORLD Co., Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

sodium fluoride

INACTIVE INGREDIENT

menthol, DL-alanine, polydextrose, sodium benzoate, sodium saccharin, sodium acetate, citric acid flavor lemon, purified water

PURPOSE

for dental care

KEEP OUT OF REACH OF CHILDREN

keep out or reach of the children

INDICATIONS & USAGE

rinse for 30 seconds with one pack of mouthwash morning and night

WARNINGS

do not swallow

DOSAGE & ADMINISTRATION

for dental use only

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

SOONSOO GARGLE 
sodium fluoride mouthwash

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 61526-1001
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 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
XYLITOL (UNII: VCQ006KQ1E)
MENTHOL (UNII: L7T10EIP3A)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 61526-1001-1	11 mL in 1 POUCH

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part355	11/16/2013

Labeler - Chang Hwa Dang Co., Ltd. (690253794)

Registrant - Chang Hwa Dang Co., Ltd. (690253794)

Establishment
Name	Address	ID/FEI	Business Operations
ECOWORLD Co., Ltd		688735061	manufacture(61526-1001)