Hello®

Hello®
SPL v1
SPL
SPL Set ID d6c4ac9e-f55e-4ebc-bd6a-e39eaeb4f813
Route
DENTAL
Published
Effective Date 2025-11-11
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Fluoride Ion (1.1 mg)
Inactive Ingredients
Water Calcium Carbonate Glycerin Hydrated Silica Lauryl Glucoside Sodium Methyl Cocoyl Taurate Carboxymethylcellulose Sodium, Unspecified Benzyl Alcohol Sodium Carbonate Sodium Pyrophosphate Cocamidopropyl Betaine Rebaudioside A Acrylates/c10-30 Alkyl Acrylate Crosspolymer (60000 Mpa.s) Carbomer Homopolymer, Unspecified Type Sodium Bicarbonate Xanthan Gum

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
OTC MONOGRAPH DRUG Active Since 2026-01-01

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

water, calcium carbonate, glycerin, hydrated silica, lauryl glucoside, sodium methyl cocoyl taurate, flavor, cellulose gum, benzyl alcohol, sodium carbonate, tetrasodium pyrophosphate, cocamidopropyl betaine, rebaudioside a, acrylates/c10-30 alkyl acrylate crosspolymer, carbomer, sodium bicarbonate, xanthan gum.

Principal Display Panel 113 G Tube Carton

hello®

whipped

fluoride toothpaste

cavity fighting

+ foaming

peppermint stick flavor

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)

water, calcium carbonate, glycerin, hydrated silica, lauryl glucoside, sodium methyl cocoyl taurate, flavor, cellulose gum, benzyl alcohol, sodium carbonate, tetrasodium pyrophosphate, cocamidopropyl betaine, rebaudioside a, acrylates/c10-30 alkyl acrylate crosspolymer, carbomer, sodium bicarbonate, xanthan gum.

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

hello®

whipped

fluoride toothpaste

cavity fighting

+ foaming

peppermint stick flavor

NET WT 4.0 OZ (113 g)


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)