HELLO NATURALLY FRESH ANTISEPTIC- menthol, unspecified form mouthwash

Hello by

Drug Labeling and Warnings

Hello by is a Otc medication manufactured, distributed, or labeled by Hello Products LLC, Accupac. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

Menthol 0.2%

Purpose

Antiseptic

Use

First aid to help protect against oral infection.

Warnings

Ask a dentist if symptoms persist or condition worsens after regular use.

Keep out of reach of children under 6 years of age. If more than used for rinsing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

Directions

• adults and children 12 years of age and older: Rinse for 30 seconds with 20mL (about 1 capful) twice a day. Do not swallow.
• children 6 years to under 12 years of age: supervise use.
• children under 6 years of age: do not use

Inactive ingredients

purified water, vegetable glycerin, polysorbate 80, flavor, xylitol, erythritol, poloxamer 407, sodium benzoate and tea tree oil.

Other Information

this rinse is not intended to replace brushing or flossing.

Questions?

1-855-444-3556

SPL UNCLASSIFIED SECTION

Dist. by Hello Products LLC
Montclair, NJ 07042

PRINCIPAL DISPLAY PANEL - 473 mL Bottle Label

naturally
friendly™
hello®

naturally fresh™
antiseptic mouthwash

natural fresh mint
with farm grown peppermint

kills germs
freshens breath
rocks tastebuds
no alcohol

never tested
on animals

16 FL OZ (473mL)

INGREDIENTS AND APPEARANCE

HELLO   NATURALLY FRESH ANTISEPTIC
menthol, unspecified form mouthwash

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55882-6102
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Menthol, Unspecified Form (UNII: L7T10EIP3A) (Menthol, Unspecified Form - UNII:L7T10EIP3A)	Menthol, Unspecified Form	0.2 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
Water (UNII: 059QF0KO0R)
Glycerin (UNII: PDC6A3C0OX)
Polysorbate 80 (UNII: 6OZP39ZG8H)
Xylitol (UNII: VCQ006KQ1E)
Erythritol (UNII: RA96B954X6)
Poloxamer 407 (UNII: TUF2IVW3M2)
Tea tree oil (UNII: VIF565UC2G)
Sodium benzoate (UNII: OJ245FE5EU)

Product Characteristics
Color		Score
Shape		Size
Flavor	MINT	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 55882-6102-1	473 mL in 1 BOTTLE; Type 0: Not a Combination Product	01/09/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part356	01/09/2019

Labeler - Hello Products LLC (040714890)

Establishment
Name	Address	ID/FEI	Business Operations
Accupac		071609663	MANUFACTURE(55882-6102)