Hellotis Mouthwash by iONEBIO INC. / ECOWORLDPHARM CO .,LTD

Hellotis Mouthwash by

Drug Labeling and Warnings

Hellotis Mouthwash by is a Otc medication manufactured, distributed, or labeled by iONEBIO INC., ECOWORLDPHARM CO .,LTD. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

HELLOTIS MOUTHWASH- sodium fluoride liquid 
iONEBIO INC.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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ACTIVE INGREDIENT

Sodium Fluoride 0.02%

INACTIVE INGREDIENTS

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

PURPOSE

Anti-cavity, Anti-halitosis

WARNINGS

■ 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

KEEP OUT OF REACH OF CHILDREN

Uses

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

Directions

■ 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

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

HELLOTIS MOUTHWASH 
sodium fluoride liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 82500-010
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	0.0022 g  in 11 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
XYLITOL (UNII: VCQ006KQ1E)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)

Product Characteristics
Color		Score
Shape		Size
Flavor	APPLE	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 82500-010-02	30 in 1 CARTON	12/01/2021	07/01/2023
1	NDC: 82500-010-01	11 mL in 1 PACKET; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part355	12/01/2021	07/01/2023

Labeler - iONEBIO INC. (694983432)

Registrant - iONEBIO INC. (694983432)

Establishment
Name	Address	ID/FEI	Business Operations
ECOWORLDPHARM CO .,LTD		688735061	manufacture(82500-010)

Revised: 7/2023

Document Id: 01d3fa32-6baa-3681-e063-6294a90a57ce

34390-5

Set id: 41e13cc5-75d9-40f1-8be2-be8a79e4390f

Version: 2

Effective Time: 20230731

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