DOCTOR-CLEAN- sodium fluoride mouthwash 
Bowon Dental 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


menthol, DL-alanine, polydextrose, sodium benzoate, sodium saccharin, sodium acetate, citric acid flavor lemon, purified water


for dental care


keep out or reach of the children


rinse for 30 seconds with one pack of mouthwash morning and night


do not swallow


for dental use only


package label
DOCTOR-CLEAN 
sodium fluoride mouthwash
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61119-1001
Route of AdministrationDENTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION0.02 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
XYLITOL (UNII: VCQ006KQ1E)  
MENTHOL (UNII: L7T10EIP3A)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:61119-1001-111 mL in 1 POUCH; Type 0: Not a Combination Product08/01/202308/28/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35511/16/201308/28/2023
Labeler - Bowon Dental Co., Ltd (687249958)
Registrant - Bowon Dental Co., Ltd (687249958)
Establishment
NameAddressID/FEIBusiness Operations
ECOWORLD Co., Ltd688735061manufacture(61119-1001)

Revised: 8/2023
Document Id: 03f10289-5f8e-60d9-e063-6294a90a1de1
Set id: 60060c12-5c0e-4ee3-a3be-9e95bbfa665d
Version: 2
Effective Time: 20230827
 
Bowon Dental Co., Ltd