Hello®

Hello®
SPL v1
SPL
SPL Set ID 9429d492-0349-4c1b-aa45-e0a8dd505ec3
Route
DENTAL
Published
Effective Date 2025-11-11
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Cetylpyridinium (15 mg)
Inactive Ingredients
Water Glycerin Aloe Vera Leaf Polysorbate 80 Erythritol Xylitol Poloxamer 407 Coconut Oil Sodium Benzoate Citric Acid Monohydrate Rebaudioside A Tea Tree Oil

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2026-01-01

Description

Drug Facts

Purpose

Antigingivitis/Antiplaque


Medication Information

Purpose

Antigingivitis/Antiplaque

Description

Drug Facts

Uses
  • 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
Section 42229-5

Drug Facts

Section 50565-1

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 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
Questions?

1-855-444-3556

Active Ingredient

Cetylpyridinium Chloride 0.075%

Other Information
  • this rinse is not intended to replace brushing or flossing.
Inactive Ingredients

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

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.
Principal Display Panel 520 Ml Bottle Label

hello®

extra minty

antigingivitis/antiplaque mouthwash

with extra cooling

no alcohol • no fluoride • no dyes

made with farm grown mint

17.6 FL OZ (1.1 PT) 520 mL

PS0086078


Structured Label Content

Uses
  • 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
Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

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 Poison Control Center right away.

Purpose

Antigingivitis/Antiplaque

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
Questions?

1-855-444-3556

Active Ingredient (Active ingredient)

Cetylpyridinium Chloride 0.075%

Other Information (Other information)
  • this rinse is not intended to replace brushing or flossing.
Inactive Ingredients (Inactive ingredients)

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

Stop Use and Ask A Dentist If (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.
Principal Display Panel 520 Ml Bottle Label (PRINCIPAL DISPLAY PANEL - 520 mL Bottle Label)

hello®

extra minty

antigingivitis/antiplaque mouthwash

with extra cooling

no alcohol • no fluoride • no dyes

made with farm grown mint

17.6 FL OZ (1.1 PT) 520 mL

PS0086078


Advanced Ingredient Data


Raw Label Data

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