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The Gargle by PBS Co., Ltd.

Medically reviewed on January 22, 2018

Dosage form: mouthwash
Ingredients: SODIUM FLUORIDE 0.02mg in 100mL
Labeler: PBS Co., Ltd.
NDC Code: 41525-7001

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


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


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


THE GARGLE 
sodium fluoride mouthwash
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41525-7001
Route of AdministrationDENTALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (FLUORIDE ION) FLUORIDE ION0.02 mg  in 100 mL
Inactive Ingredients
Ingredient NameStrength
ALLANTOIN 
XYLITOL 
CITRIC ACID MONOHYDRATE 
Packaging
#Item CodePackage Description
1NDC:41525-7001-1600 mL in 1 BOTTLE
2NDC:41525-7001-2780 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35501/22/2015
Labeler - PBS Co., Ltd. (690329669)
Registrant - PBS Co., Ltd. (690329669)
Establishment
NameAddressID/FEIOperations
PBS Co., Ltd.690329669manufacture(41525-7001)

 
PBS Co., Ltd.

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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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