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.

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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 Type HUMAN OTC DRUG Item Code (Source) NDC:59303-1001
Route of Administration DENTAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Sodium Fluoride (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION 20 mg  in 100000 mL
Inactive Ingredients
Ingredient Name Strength
GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
XYLITOL (UNII: VCQ006KQ1E)  
GRAPEFRUIT (UNII: O82C39RR8C)  
APPLE (UNII: B423VGH5S9)  
PEPPERMINT (UNII: V95R5KMY2B)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:59303-1001-3 100 in 1 PACKAGE
1 NDC:59303-1001-2 3 in 1 PACKAGE
1 NDC:59303-1001-1 12 mL in 1 CONTAINER
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part355 07/13/2013
Labeler - PISHONANC Co, Ltd (557787661)
Registrant - PISHONANC Co, Ltd (557787661)
Establishment
Name Address ID/FEI Business Operations
PISHONANC Co, Ltd 557787661 manufacture(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