OLIDENTAL GARGLE- sodium fluoride liquid 
AJU PHARM CO., LTD.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Drug Facts

Sodium Fluoride 0.02%

Anticavity

Aids in the prevention of dental cavities

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

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

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

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

image description

OLIDENTAL GARGLE 
sodium fluoride liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70417-001
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION0.06 mg  in 300 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70417-001-01300 mL in 1 BOTTLE; Type 0: Not a Combination Product01/20/2016
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35501/20/2016
Labeler - AJU PHARM CO., LTD. (687982405)
Registrant - AJU PHARM CO., LTD. (687982405)
Establishment
NameAddressID/FEIBusiness Operations
AJU PHARM CO., LTD.687982405manufacture(70417-001)

Revised: 1/2016
Document Id: f6e97c6c-a3a0-4054-822c-4c02a1d6e4e6
Set id: 71f907b8-8f28-4fd2-a035-b79cbf9ab860
Version: 1
Effective Time: 20160120
 
AJU PHARM CO., LTD.