OLIDENTAL GARGLE- sodium fluoride liquid

Olidental Gargle by

Drug Labeling and Warnings

Olidental Gargle by is a Otc medication manufactured, distributed, or labeled by AJU PHARM CO., LTD.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Sodium Fluoride 0.02%

PURPOSE

Anticavity

INDICATIONS & USAGE

Aids in the prevention of dental cavities

DOSAGE & ADMINISTRATION

Adults and children 12 years of age and older:
Use twice daily after brushing your teeth with a toothpaste
Vigorously swish 10mL (2 teaspoonfuls) of rinse between your teeth for 1 minute and then spit out
Do not swallow the rinse
Do not eat or drink for 30 minutes after rinsing
Supervise children as necessary until capable of suing without supervisor

Children under 12 years of age: consult a dentist or doctor

WARNINGS

Stop use and ask a dentist if oral irritation or tooth sensitivity occurs

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. If more than used for rinsing is accidentally swallowed, get medical help or contact a Poison Control Center right away

INACTIVE INGREDIENT

Glycerin, Allantoin, Xylitol, Stevioside, Acetic acid, Sodium bicarbonate, Sodium acetate, Olive leaf extract, Sodium Benzoate, Green Tea Extract, Sodium Saccharin, L-Menthol, Citrus flavoring, Lemon flavoring, Propolis Extract, Lemon Oil, Cacao Color, Purified water

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

OLIDENTAL GARGLE 
sodium fluoride liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70417-001
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	0.06 mg  in 300 mL

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)
ALLANTOIN (UNII: 344S277G0Z)
XYLITOL (UNII: VCQ006KQ1E)
STEVIOSIDE (UNII: 0YON5MXJ9P)
ACETIC ACID (UNII: Q40Q9N063P)
SODIUM BICARBONATE (UNII: 8MDF5V39QO)
SODIUM ACETATE (UNII: 4550K0SC9B)
OLEA EUROPAEA LEAF (UNII: MJ95C3OH47)
SODIUM BENZOATE (UNII: OJ245FE5EU)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
LEVOMENTHOL (UNII: BZ1R15MTK7)
PROPOLIS WAX (UNII: 6Y8XYV2NOF)
LEMON OIL (UNII: I9GRO824LL)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70417-001-01	300 mL in 1 BOTTLE; Type 0: Not a Combination Product	01/20/2016

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part355	01/20/2016

Labeler - AJU PHARM CO., LTD. (687982405)

Registrant - AJU PHARM CO., LTD. (687982405)

Establishment
Name	Address	ID/FEI	Business Operations
AJU PHARM CO., LTD.		687982405	manufacture(70417-001)