SOOM MOUTHWASH- sodium fluoride liquid 
BD TECHNOLOGY 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

Water
Sodium Fluoride
Allantoin
Erythritol
xylitol
Sodium benzoate
Glycerin
Propylene Glycol
PEG-40 Hydrogenated Castor Oil
L-Menthol
zinc gluconate
sodium citrate
Fragrance

prevention of gingvitis, periodontitis, cavity, periodontal disease gum disease

KEEP OUT OF REACH OF THE CHILDREN

spit out the appropriate amount (120~15ml) for about 30 seconds after mouthing, and then brush the tooth bybrushing

For oral use only.

When using this product keep out of eyes. If contact with eyes occurs, rinse promptly and thoroughly with water.

Stop use and ask a doctor if significant irritation or sensitization develops.

for oral use only

label

SOOM MOUTHWASH 
sodium fluoride liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73927-0005
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) SODIUM FLUORIDE0.02 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
GLYCERIN (UNII: PDC6A3C0OX)  
ALLANTOIN (UNII: 344S277G0Z)  
WATER (UNII: 059QF0KO0R)  
ERYTHRITOL (UNII: RA96B954X6)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:73927-0005-111 mL in 1 POUCH; Type 0: Not a Combination Product06/10/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35506/10/2020
Labeler - BD TECHNOLOGY CO., LTD (695005161)
Registrant - BD TECHNOLOGY CO., LTD (695005161)
Establishment
NameAddressID/FEIBusiness Operations
BD TECHNOLOGY CO., LTD.695005161manufacture(73927-0005) , label(73927-0005)

Revised: 6/2020
Document Id: a7b8cca4-7b78-6efc-e053-2a95a90a5841
Set id: a7b8a58d-13fd-896e-e053-2995a90a5ec9
Version: 1
Effective Time: 20200610
 
BD TECHNOLOGY CO., LTD