Hello® Naturally Fresh™ Antiseptic

Hello Naturally Fresh Antiseptic by

Drug Labeling and Warnings

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

Drug Details [pdf]

HELLO NATURALLY FRESH ANTISEPTIC- menthol, unspecified form mouthwash 
Hello Products LLC

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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Hello® Naturally Fresh™ Antiseptic

Drug Facts

Active ingredient

Menthol 0.2%

Purpose

Antiseptic

Use

aids in the protection 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 20 mL (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

Other information

• this rinse is not intended to replace brushing or flossing.

Inactive ingredients

purified water, vegetable glycerin, polysorbate 80, flavor, erythritol, xylitol, poloxamer 407, citric acid, sodium benzoate, melaleuca alternifolia (tea tree) leaf oil.

Questions?

1-855-444-3556

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.

16 FL OZ (1 PT) 473 mL

44956

HELLO NATURALLY FRESH ANTISEPTIC 
menthol, unspecified form mouthwash

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55882-3499
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	200 mg  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
ERYTHRITOL (UNII: RA96B954X6)
XYLITOL (UNII: VCQ006KQ1E)
POLOXAMER 407 (UNII: TUF2IVW3M2)
CITRIC ACID ACETATE (UNII: DSO12WL7AU)
SODIUM BENZOATE (UNII: OJ245FE5EU)
TEA TREE OIL (UNII: VIF565UC2G)

Product Characteristics
Color		Score
Shape		Size
Flavor	MINT	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 55882-3499-3	473 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/21/2021	03/30/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part356	03/21/2021	03/30/2023

Labeler - Hello Products LLC (040714890)

Revised: 4/2023

Document Id: 4f5b3efa-494d-4931-bdf4-d28d917b81e0

34390-5

Set id: 3c7faad7-9c02-ddec-9d86-9b6218ff8ce7

Version: 7

Effective Time: 20230403