TRUWELL DENTIWASH- sodium fluoride liquid 
ECOWORLDPHARM CO.,LTD

----------

Drug Facts

sodium fluoride

purified water, glycerin, xylitol, green tea extract, acetic acid, strawberry flavoring, sodium acetate, grapefruit seed extract, sodium benzoate, L-menthol, sodium saccharin, chitosan

aids in the prevention of dental cavities

KEEP OUT OF REACH OF THE CHILDREN

Adults and children 6 years of age and older:

use twoce a day after brishing your teeth with a toothpaste

vigorously swish contents of one (1) 11mL packet between your teeth for 1 minute and then spit out

do not swallow the rinse

do not eat or drink for 30 minutes after rinsing

instruct children under 12 years of age in good rinsing habits (to minimize swallowing)

supervise children as necessary until capable of using without supervision

Children uder 6 years of age: consult a dentist or doctor

if more than used for rinsing is accidentally swallowed, get medical help or contact a Poison Control Center right away

for dental use only

label

TRUWELL DENTIWASH 
sodium fluoride liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61284-0013
Route of AdministrationDENTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) SODIUM FLUORIDE0.05 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
XYLITOL (UNII: VCQ006KQ1E)  
MALIC ACID (UNII: 817L1N4CKP)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:61284-0013-2250 in 1 PACKAGE10/05/2023
1NDC:61284-0013-111 mL in 1 PACKAGE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02110/05/2023
Labeler - ECOWORLDPHARM CO.,LTD (688735061)
Registrant - ECOWORLDPHARM CO.,LTD (688735061)
Establishment
NameAddressID/FEIBusiness Operations
ECOWORLDPHARM CO.,LTD688735061manufacture(61284-0013)

Revised: 10/2023
Document Id: 06f0ddf8-e05d-56ec-e063-6294a90abcfa
Set id: 06f0dd87-add4-3167-e063-6294a90afad7
Version: 1
Effective Time: 20231004
 
ECOWORLDPHARM CO.,LTD