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

Principal Display Panel - 473 mL Bottle Label
HELLO NATURALLY FRESH ANTISEPTIC 
menthol, unspecified form mouthwash
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55882-3499
Route of AdministrationDENTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL, UNSPECIFIED FORM - UNII:L7T10EIP3A) MENTHOL, UNSPECIFIED FORM200 mg  in 100 mL
Inactive Ingredients
Ingredient NameStrength
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    
ShapeSize
FlavorMINTImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:55882-3499-3473 mL in 1 BOTTLE; Type 0: Not a Combination Product03/21/202103/30/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart35603/21/202103/30/2023
Labeler - Hello Products LLC (040714890)

Revised: 4/2023
Document Id: 4f5b3efa-494d-4931-bdf4-d28d917b81e0
Set id: 3c7faad7-9c02-ddec-9d86-9b6218ff8ce7
Version: 7
Effective Time: 20230403
 
Hello Products LLC