HELLO PEACE OUT PLAQUE- cetypyridinium chlloride mouthwash

Hello Peace Out Plaque by

Drug Labeling and Warnings

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

Drug Details [pdf]

Hello Peace Out Plaque

peace out, plaque antigingivitis

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, an 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 space between the teeth.These may be signs or symptoms of periodontitis, a serious form of gum disease.

Keep out of the 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 20mL of rinse between your teeth twice 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

Other information

This rinse is not intended to replace brushing or flossing.

Inactive ingredients

water, glycerin, aloe barbadensis leaf, polysorbate 80, xylitol, erythritol, poloxamer 407, flavor, sodium benzoate, cocos nucifera (coconut) oil 1, citric acid, melaleuca alternifolia (tea tree) leaf oil 1, rabaudioside a 1.

1 certified organic

Questions?

1-855-444-3556

Dist. by Hello Products

LLC Montclair, NJ 07042

SPL UNCLASSIFIED SECTION

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

INGREDIENTS AND APPEARANCE

HELLO PEACE OUT PLAQUE 
cetypyridinium chlloride mouthwash

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 44038-0683
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
ALOE VERA LEAF (UNII: ZY81Z83H0X)
ERYTHRITOL (UNII: RA96B954X6)
COCONUT OIL (UNII: Q9L0O73W7L)
SODIUM BENZOATE (UNII: OJ245FE5EU)
STEVIA REBAUDIUNA LEAF (UNII: 6TC6NN0876)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
TEA TREE OIL (UNII: VIF565UC2G)
WATER (UNII: 059QF0KO0R)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
XYLITOL (UNII: VCQ006KQ1E)
POLOXAMER 407 (UNII: TUF2IVW3M2)
GLYCERIN (UNII: PDC6A3C0OX)

Product Characteristics
Color		Score
Shape		Size
Flavor	MINT	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 44038-0683-1	473 mL in 1 BOTTLE; Type 0: Not a Combination Product	07/01/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	505G(a)(3)	07/01/2023	12/30/2027

Labeler - Accupac LLC (071609663)

Registrant - Accupac LLC (061595175)

Establishment
Name	Address	ID/FEI	Business Operations
Accupac LLC		061595175	manufacture(44038-0683)