Hello®

Hello®
SPL v3
SPL
SPL Set ID dec56ca7-d187-03c5-c487-c8ff7d0bf52a
Route
DENTAL
Published
Effective Date 2023-08-04
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 Sorbitol Xylitol Erythritol Activated Charcoal Xanthan Gum Sodium Bicarbonate Sodium Cocoyl Glutamate Potassium Citrate Cocamidopropyl Betaine Coconut Oil Rebaudioside A Sodium Pyrophosphate

Identifiers & Packaging

Pill Appearance
Color: black
Marketing Status
OTC MONOGRAPH DRUG Completed Since 2023-07-01 Until 2026-07-31

Description

Drug Facts

Purpose

Anticavity


Medication Information

Purpose

Anticavity

Description

Drug Facts

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.

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
Questions?

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

Active Ingredient

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

Inactive Ingredients

glycerin, water, hydrated silica, sorbitol, xylitol, erythritol, charcoal powder, flavor, xanthan gum, sodium bicarbonate, sodium cocoyl glutamate, potassium citrate, cocamidopropyl betaine, cocos nucifera (coconut) oil

certified organic
,rebaudioside a
, tetrasodium pyrophosphate.

Principal Display Panel 113 G Tube Carton

naturally

friendly®

hello®

epic

whitening

anticavity

fluoride toothpaste

activated

charcoal

fresh mint + coconut oil

NET WT 4.0 OZ (113 g)


Structured Label Content

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.

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
Questions?

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

Active Ingredient (Active ingredient)

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

Inactive Ingredients (Inactive ingredients)

glycerin, water, hydrated silica, sorbitol, xylitol, erythritol, charcoal powder, flavor, xanthan gum, sodium bicarbonate, sodium cocoyl glutamate, potassium citrate, cocamidopropyl betaine, cocos nucifera (coconut) oil

certified organic
,rebaudioside a
, tetrasodium pyrophosphate.

Principal Display Panel 113 G Tube Carton (PRINCIPAL DISPLAY PANEL - 113 g Tube Carton)

naturally

friendly®

hello®

epic

whitening

anticavity

fluoride toothpaste

activated

charcoal

fresh mint + coconut oil

NET WT 4.0 OZ (113 g)


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)