Hello® peace out, plaque antigingivitis 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]

HELLO  PEACE OUT, PLAQUE ANTIGINGIVITIS- cetylpyridinium chloride 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®
peace out, plaque antigingivitis mouthwash

Drug Facts

Active ingredient

Cetylpyridinium chloride 0.075%

Purpose

Antigingivitis/Antiplaque

Use

• helps prevent and reduce plaque and gingivitis
• helps control plaque bacteria that contribute to the development of gingivitis, and early form of gum disease, and bleeding gums

Warnings

Stop use and ask a dentist if

• gingivitis, bleeding, or redness persist for more than two weeks
• you have painful or swollen gums, pus from the gum line, loose teeth, or increasing spacing between the teeth. These may be signs or symptoms of periodontitis, a serious form of gum disease.

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: vigorously swish 20 mL of rinse between your teeth twice a day for 30 seconds, then spit out. Do not swallow the rinse.
• children 6 years to under 12 years of age: supervise use
• children under 6 years of age: do not use

Inactive ingredients

water, glycerin, aloe barbadensis leaf juice, polysorbate 80, erythritol, xylitol, poloxamer 407, flavor, cocos nucifera (coconut) oil1, sodium benzoate, citric acid, rebaudioside A1, melaleuca alternifolia (tea tree) leaf oil.

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®

peace out, plaque
antigingivitis/antiplaque mouthwash

natural mint
with aloe vera + coconut oil

promotes healthy gums.
freshens like crazy.
no alcohol, no brainer.

16 FL OZ (473 mL)

PS0038424
45052

HELLO   PEACE OUT, PLAQUE ANTIGINGIVITIS
cetylpyridinium chloride mouthwash

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55882-6200
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P) (CETYLPYRIDINIUM - UNII:CUB7JI0JV3)	CETYLPYRIDINIUM CHLORIDE	15 mg  in 20 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
ERYTHRITOL (UNII: RA96B954X6)
XYLITOL (UNII: VCQ006KQ1E)
POLOXAMER 407 (UNII: TUF2IVW3M2)
COCONUT OIL (UNII: Q9L0O73W7L)
SODIUM BENZOATE (UNII: OJ245FE5EU)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
STEVIA REBAUDIUNA LEAF (UNII: 6TC6NN0876)
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: 55882-6200-1	473 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/25/2022	07/01/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part356	04/25/2022	07/01/2023

Labeler - Hello Products LLC (040714890)

Revised: 7/2022

Document Id: 98029b62-a8ff-408d-9605-2bb08e65dba7

34390-5

Set id: 334c3370-1a45-4e08-a3c2-6c9b1907fbd1

Version: 5

Effective Time: 20220720