Truwell Kids Dentiwash

Manufacturer: ECOWORLDPHARM CO.,LTD
Effective date: 2023-10-04
Label type: HUMAN OTC DRUG LABEL
Version: 2
Source: full-release
Hydrated at: 2026-05-31 23:56:25

Label at a glance#

ProductTruwell Kids Dentiwash

Active ingredientSODIUM FLUORIDE

Label structure8 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

sodium fluoride

INACTIVE INGREDIENT SECTION

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

OTC - PURPOSE SECTION

aids in the prevention of dental cavities

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

KEEP OUT OF REACH OF THE CHILDREN

INDICATIONS & USAGE SECTION

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 SECTION

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

DOSAGE & ADMINISTRATION SECTION

for dental use only

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
313029	sodium fluoride 0.02 % (fluoride ion 0.01 % ) Oral Rinse	PSN	2
313029	sodium fluoride 0.2 MG/ML Mouthwash	SCD	2
313029	sodium fluoride 0.02 % (fluoride ion 0.009 % ) Oral Rinse	SY	2
313029	sodium fluoride 0.02 % (fluoride ion 0.01 % ) Oral Rinse	SY	2

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
3c386306-c48a-413e-bb69-70cb268496f3	Product name	1	20210727

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
61284-0011-2	2025-01-30	C162847	48780-1	2cef2736-ab73-d83d-e063-dadaa90ab31f	Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
61284-0011-1	Truwell Kids Dentiwash	11 mL in 1 PACKAGE	LIQUID	11		2
61284-0011-2	Truwell Kids Dentiwash	30 in 1 PACKAGE	LIQUID	30		2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
61284-0011	TRUWELL KIDS DENTIWASH (SODIUM FLUORIDE) LIQUID [ECOWORLDPHARM CO.,LTD]	2	2 package rows	20231005_06e9dc12-acc5-3d79-e063-6294a90ad7a6.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 6 matching rows.

Truwell Kids Dentiwash
sodium fluoride
XYLITOL
GLYCERIN
WATER
FLUORIDE ION

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
61284-0011	61284-0011-1, 61284-0011-2

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 4 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
XYLITOL	VCQ006KQ1E	IACT
GLYCERIN	PDC6A3C0OX	IACT
WATER	059QF0KO0R	IACT
SODIUM FLUORIDE	8ZYQ1474W7	ACTIB

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
06ef3495-2b9e-b148-e063-6394a90abdc4			06e9dc12-acc5-3d79-e063-6294a90ad7a6	2023-10-04	Warnings	Exact identifier spl id: 06ef3495-2b9e-b148-e063-6394a90abdc4 spl set id: 06e9dc12-acc5-3d79-e063-6294a90ad7a6

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.