TRUWELL KIDS DENTIWASH- sodium fluoride liquid

Truwell Kids Dentiwash by

Drug Labeling and Warnings

Truwell Kids Dentiwash by is a Otc medication manufactured, distributed, or labeled by ECOWORLDPHARM CO.,LTD. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

sodium fluoride

INACTIVE INGREDIENT

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

PURPOSE

aids in the prevention of dental cavities

KEEP OUT OF REACH OF CHILDREN

KEEP OUT OF REACH OF THE CHILDREN

INDICATIONS & USAGE

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

WARNINGS

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

DOSAGE & ADMINISTRATION

for dental use only

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

TRUWELL KIDS DENTIWASH 
sodium fluoride liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 61284-0011
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	SODIUM FLUORIDE	0.02 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
XYLITOL (UNII: VCQ006KQ1E)
GLYCERIN (UNII: PDC6A3C0OX)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 61284-0011-2	30 in 1 PACKAGE	10/05/2023
1	NDC: 61284-0011-1	11 mL in 1 PACKAGE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M021	10/05/2023

Labeler - ECOWORLDPHARM CO.,LTD (688735061)

Registrant - ECOWORLDPHARM CO.,LTD (688735061)

Establishment
Name	Address	ID/FEI	Business Operations
ECOWORLDPHARM CO.,LTD		688735061	manufacture(61284-0011)