HELLO- aloe vera leaf 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®

Drug Facts

Active ingredient

Aloe vera 20%

Purpose

Antigingivitis/antiplaque

Use

helps prevent and reduce plaque and gingivitis.

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 (4 teaspoonfuls) 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, xylitol, erythritol, flavor, poloxamer 407, coconut oil1 and sodium benzoate.

1
certified organic

Other Information

this rinse is not intended to replace brushing or flossing.

Questions?

1-855-444-3556

Dist. by Hello Products LLC
Montclair, NJ 07042

PRINCIPAL DISPLAY PANEL - 473 mL Bottle Label

naturally
friendly™
hello®

naturally healthy™
antigingivitis mouthwash

natural mint
with aloe vera + coconut oil

promotes healthy gums
helps prevent plaque + gingivitis
freshens breath
no alcohol

never tested
on animals

16 FL OZ (473mL)

Principal Display Panel - 473 mL Bottle Label
HELLO 
aloe vera leaf mouthwash
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55882-6098
Route of AdministrationDENTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALOE VERA LEAF (UNII: ZY81Z83H0X) (ALOE VERA LEAF - UNII:ZY81Z83H0X) ALOE VERA LEAF20 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
GLYCERIN (UNII: PDC6A3C0OX)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
XYLITOL (UNII: VCQ006KQ1E)  
ERYTHRITOL (UNII: RA96B954X6)  
POLOXAMER 407 (UNII: TUF2IVW3M2)  
COCONUT OIL (UNII: Q9L0O73W7L)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
Product Characteristics
Color    Score    
ShapeSize
FlavorMINTImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:55882-6098-1473 mL in 1 BOTTLE; Type 0: Not a Combination Product06/01/201806/30/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart35606/01/201806/30/2023
Labeler - Hello Products LLC (040714890)
Establishment
NameAddressID/FEIBusiness Operations
Accupac071609663MANUFACTURE(55882-6098)
Establishment
NameAddressID/FEIBusiness Operations
Nutrix117341868MANUFACTURE(55882-6098)

Revised: 3/2021
Document Id: 0dfb1b46-258b-4f03-91ad-f2013883ecc1
Set id: 25632c97-e792-447f-b690-3c174f15315b
Version: 3
Effective Time: 20210326
 
Hello Products LLC