Hellotis Mouthwash

Manufacturer
iONEBIO INC. | ECOWORLDPHARM CO .,LTD
Effective date
2022-01-11
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-01 22:18:04

Label at a glance#

ProductHellotis Mouthwash
Active ingredientSodium Fluoride
Label structure9 sections

Indications and uses

■ prevents cavities and removes bad breath. ■ helps control plaque that leads to gingivitis

Dosage and administration

■ Adults and children 6 years of age and older: Twice a day/Swish 11mL(1 sachet) for 30 seconds and spit it out.

Label contents#

Full prescribing information#

ACTIVE INGREDIENT

OTC - ACTIVE INGREDIENT SECTION

Sodium Fluoride 0.02%

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

Water, Xylitol, Sodium saccharin, Acetic acid, Sodium acetate, DL-alanine, Chitosan, Polydextrose, Sodium benzoate, Apple spearmint flavor, Maple flavor, L-menthol

PURPOSE

OTC - PURPOSE SECTION

Anti-cavity, Anti-halitosis

WARNINGS

WARNINGS SECTION

■ Please follow the designated usage and dosage.
■ If used by children, have them use it under the guidance and supervision of their parents or guardians.
■ Use it only for oral rinse and do not use it for internal or other purposes.
■ Keep out of reach of children.
■ Do not switch to other containers for quality preservation
■ Keep in a cool place away from direct sunlight.

KEEP OUT OF REACH OF CHILDREN

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

KEEP OUT OF REACH OF CHILDREN

Uses

INDICATIONS & USAGE SECTION

■ prevents cavities and removes bad breath.
■ helps control plaque that leads to gingivitis

Directions

DOSAGE & ADMINISTRATION SECTION

■ Adults and children 6 years of age and older: Twice a day/Swish 11mL(1 sachet) for 30 seconds and spit it out.

Other information

OTHER SAFETY INFORMATION

■ Store at room temperature (33°-86°F).

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Image of cartonImage of carton

Products#

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NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
82500-01082500-010-01, 82500-010-02

Ingredients#

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

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

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
01d3fa32-6baa-3681-e063-6294a90a57ce41e13cc5-75d9-40f1-8be2-be8a79e4390f2023-07-31WarningsExact identifier
spl set id: 41e13cc5-75d9-40f1-8be2-be8a79e4390f

Reported adverse events (FAERS/openFDA)#

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