hello®

hello®
SPL v4
SPL
SPL Set ID 5ad241e1-6bfc-7863-6a7a-100753651f0a
Route
dental
Published
Effective Date 2024-10-11
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
fluoride ion (1.1 mg)
Inactive Ingredients
glycerin water hydrated silica calcium carbonate sorbitol erythritol xylitol xanthan gum sodium bicarbonate potassium citrate sodium cocoyl glutamate cocamidopropyl betaine coconut oil rebaudioside a tea tree oil

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
otc monograph drug completed Since 2023-07-01 Until 2027-09-30

Purpose

Anticavity

Description

Drug Facts


Medication Information

Purpose

Anticavity

Directions
adults and children 2 years of age and older brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or physician
children 2 to 6 years use only a pea sized amount and supervise child's brushing and rinsing (to minimize swallowing)
children under 2 years ask a dentist or physician
Inactive Ingredients

glycerin, water, hydrated silica, calcium carbonate, sorbitol, erythritol, xylitol, flavor, xanthan gum, sodium bicarbonate, potassium citrate, sodium cocoyl glutamate, cocamidopropyl betaine, cocos nucifera (coconut) oil, rebaudioside a, melaleuca alternifolia (tea tree) leaf oil.

Description

Drug Facts

Questions?

855-HI-HELLO (1-855-444-3556)

Use

helps protect against cavities

Section 42229-5

Drug Facts

Section 50565-1

Keep out of reach of children under 6 years of age. If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

twist off cap to remove foil seal.

Section 50570-1

do not use if safety seal is missing or broken.

Active Ingredient

Sodium monofluorophosphate 0.76% (0.14% w/v fluoride ion)

Principal Display Panel 133 G Tube Carton

choose

friendly®

hello®

naturally

whitening*

anticavity

fluoride toothpaste

mint

to be

farm grown mint + coconut oil

NET WT 4.7 OZ (133 g)


Structured Label Content

Purpose

Anticavity

Directions
adults and children 2 years of age and older brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or physician
children 2 to 6 years use only a pea sized amount and supervise child's brushing and rinsing (to minimize swallowing)
children under 2 years ask a dentist or physician
Inactive Ingredients (Inactive ingredients)

glycerin, water, hydrated silica, calcium carbonate, sorbitol, erythritol, xylitol, flavor, xanthan gum, sodium bicarbonate, potassium citrate, sodium cocoyl glutamate, cocamidopropyl betaine, cocos nucifera (coconut) oil, rebaudioside a, melaleuca alternifolia (tea tree) leaf oil.

Questions?

855-HI-HELLO (1-855-444-3556)

Use

helps protect against cavities

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 brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

twist off cap to remove foil seal.

Section 50570-1 (50570-1)

do not use if safety seal is missing or broken.

Active Ingredient (Active ingredient)

Sodium monofluorophosphate 0.76% (0.14% w/v fluoride ion)

Principal Display Panel 133 G Tube Carton (PRINCIPAL DISPLAY PANEL - 133 g Tube Carton)

choose

friendly®

hello®

naturally

whitening*

anticavity

fluoride toothpaste

mint

to be

farm grown mint + coconut oil

NET WT 4.7 OZ (133 g)


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)