THE GARGLE - sodium fluoride mouthwash 
PBS 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


purified water, ethyl alcohol, allantoin, glycerin, xylitol, sodium saccharin, green tea, malic acid, lactic acid, sodium benzoate, citric acid peg-40 hydrogenated castor oil, sodium citrate, l-menthol, red ginseng ext, ulmus ext, red ginseng fragrance, mint fragrance, houttuynia ext, propolis ext, caramel color


for dental care


keep out of reach of the children


① Turn the container cap and open, pour The Gargle into the cap about 10-15ml (not to overflow the cap) and
put into mouth.
② Goggle it thoroughly all over the inner mouth about 10 seconds.
③ After ②, in order to sterilize mouth, hold the liquid in the mouth about 30 seconds and spit out


do not swallow


for oral administration


package insert
THE GARGLE 
sodium fluoride mouthwash
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41525-5001
Route of AdministrationDENTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION0.02 mg  in 100 mL
Inactive Ingredients
Ingredient NameStrength
ALLANTOIN (UNII: 344S277G0Z)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:41525-5001-210 in 1 PACKAGE
1NDC:41525-5001-111 mL in 1 POUCH
2NDC:41525-5001-3250 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35509/11/2014
Labeler - PBS Co., Ltd. (690329669)
Registrant - PBS Co., Ltd. (690329669)
Establishment
NameAddressID/FEIBusiness Operations
PBS Co., Ltd.690329669manufacture(41525-5001)

Revised: 9/2014
Document Id: a70078b9-c78a-4fd5-8b1e-0e8ac22eb2eb
Set id: f8a166bf-cdb2-4fe8-9d74-1bb95a3fc28f
Version: 1
Effective Time: 20140911
 
PBS Co., Ltd.