HANIP GARGLE APPLE FRAGRANCE - sodium fluoride mouthwash 
PISHONANC 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.

----------

Drug Facts

sodium fluoride


green tea extract, xylitol, grape fruit extract, apple fragrance, peppermint fragrance, sodium beozoate


dental care


keep out of reach of the children


- gargle a cap for about 60 seconds and then spit out
- in case of children under 6 years of age, use 1/2 cap and care for not swallowing
- before meeting, for old man or patient used easily


keep away from heat and flame


for dental use only


package insert
HANIP GARGLE APPLE FRAGRANCE 
sodium fluoride mouthwash
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:59303-1001
Route of AdministrationDENTALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Sodium Fluoride (FLUORIDE ION) FLUORIDE ION20 mg  in 100000 mL
Inactive Ingredients
Ingredient NameStrength
GREEN TEA LEAF 
XYLITOL 
GRAPEFRUIT 
APPLE 
PEPPERMINT 
SODIUM BENZOATE 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:59303-1001-3100 in 1 PACKAGE
1NDC:59303-1001-23 in 1 PACKAGE
1NDC:59303-1001-112 mL in 1 CONTAINER
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35507/13/2013
Labeler - PISHONANC Co, Ltd (557787661)
Registrant - PISHONANC Co, Ltd (557787661)
Establishment
NameAddressID/FEIBusiness Operations
PISHONANC Co, Ltd557787661manufacture(59303-1001)

Revised: 7/2013
Document Id: 9e6a9f44-820d-4499-8e56-5fb09e42865b
Set id: a5cca931-91e1-42d0-98bb-20f0501a0467
Version: 1
Effective Time: 20130713
 
PISHONANC Co, Ltd