FDA.reportPublic FDA data

Truwell Dentiwash

Manufacturer
ECOWORLDPHARM CO.,LTD
Effective date
2023-10-04
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:56:25

Label at a glance#

ProductTruwell 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

labellabel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
240698sodium fluoride 0.05 % (fluoride ion 0.02 % ) Oral RinsePSN1
240698sodium fluoride 0.5 MG/ML MouthwashSCD1
240698sodium fluoride 0.05 % (fluoride ion 0.02 % ) Oral RinseSY1

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
3c386306-c48a-413e-bb69-70cb268496f3Product name120210727

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
61284-0012-22025-01-30C16284748780-12cef2736-8248-d83d-e063-dadaa90ab31fDrug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61284-0012-1Truwell Dentiwash11 mL in 1 PACKAGELIQUID111
61284-0012-2Truwell Dentiwash30 in 1 PACKAGELIQUID301

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61284-0012TRUWELL DENTIWASH (SODIUM FLUORIDE) LIQUID [ECOWORLDPHARM CO.,LTD]12 package rows20231005_06f05b71-aff2-0b3c-e063-6294a90a788d.zip

Products#

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

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

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
61284-001261284-0012-1, 61284-0012-2

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
NameUNIIKind
XYLITOLVCQ006KQ1EIACT
MALIC ACID817L1N4CKPIACT
WATER059QF0KO0RIACT
SODIUM FLUORIDE8ZYQ1474W7ACTIB

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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
06f02221-73a3-87e5-e063-6394a90ab95106f05b71-aff2-0b3c-e063-6294a90a788d2023-10-04WarningsExact identifier
spl id: 06f02221-73a3-87e5-e063-6394a90ab951
spl set id: 06f05b71-aff2-0b3c-e063-6294a90a788d

Reported adverse events (FAERS/openFDA)#

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