Hello®

Hello®
SPL v6
SPL
SPL Set ID 48e36e06-3666-9032-b9c8-4be035e751f2
Route
DENTAL
Published
Effective Date 2025-04-15
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Fluoride Ion (1.1 mg)
Inactive Ingredients
Water Sorbitol Hydrated Silica Glycerin Xylitol Sodium Pyrophosphate Zinc Phosphate Sodium Citrate, Unspecified Form Carboxymethylcellulose Sodium, Unspecified Sodium Cocoyl Glutamate Cocamidopropyl Betaine Xanthan Gum Stevia Rebaudiuna Leaf Anhydrous Citric Acid

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-07-01

Description

Drug Facts

Purpose

Anticavity, Antigingivitis, Antisensitivity


Medication Information

Purpose

Anticavity, Antigingivitis, Antisensitivity

Description

Drug Facts

Uses
  • aids in the prevention of cavities.
  • helps prevent gingivitis.
  • helps interfere with harmful effects of plaque associated with gingivitis.
  • builds increasing protection against painful sensitivity of the teeth to cold, heat, acids, sweets, or contact.
Section 42229-5

Drug Facts

Section 50565-1

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

Section 50566-9

Stop use and ask a dentist if the sensitivity problem persists or worsens. Sensitive teeth may indicate a serious problem that may need prompt care by a dentist.

Section 50567-7

When using this product for sensitivity, do not use longer than 4 weeks unless recommended by a dentist.

Purposes

Anticavity, Antigingivitis, Antisensitivity

Directions
  • adults and children 12 years of age and older: apply at least a 1-inch strip of the product onto a soft bristled toothbrush. Brush teeth thoroughly for at least 1 minute twice a day (morning and evening) or as recommended by a dentist. Make sure to brush all sensitive areas of the teeth.
  • do not swallow.
  • children under 12 years of age: consult a dentist.
Questions?

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

Active Ingredient

Stannous Fluoride 0.454% (0.15% w/v fluoride ion)

Other Information
  • products containing stannous fluoride may produce surface staining of the teeth. Adequate toothbrushing may prevent these stains which are not harmful or permanent and may be removed by your dentist.
  • this Hello product is specially formulated to help prevent staining.
Inactive Ingredients

water, sorbitol, hydrated silica, glycerin, xylitol, tetrasodium pyrophosphate, flavor, zinc phosphate, sodium citrate, cellulose gum, sodium cocoyl glutamate, cocamidopropyl betaine, xanthan gum, rebaudioside a, citric acid.

Stop Use and Ask A Dentist If
  • gingivitis, bleeding, or redness persists for more than 2 weeks.
  • you have painful or swollen gums, pus from the gum line, loose teeth, or increasing spacing between the teeth. These may be signs of periodontitis, a serious form of gum disease.
Principal Display Panel 113 G Tube Carton

hello®

8 in 1

mighty multi-tasker

fluoride toothpaste

for anticavity, antigingivitis + antisensitivity

natural mint blend

NET WT 4.0 OZ (113 g)


Structured Label Content

Uses
  • aids in the prevention of cavities.
  • helps prevent gingivitis.
  • helps interfere with harmful effects of plaque associated with gingivitis.
  • builds increasing protection against painful sensitivity of the teeth to cold, heat, acids, sweets, or contact.
Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

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

Section 50566-9 (50566-9)

Stop use and ask a dentist if the sensitivity problem persists or worsens. Sensitive teeth may indicate a serious problem that may need prompt care by a dentist.

Section 50567-7 (50567-7)

When using this product for sensitivity, do not use longer than 4 weeks unless recommended by a dentist.

Purposes

Anticavity, Antigingivitis, Antisensitivity

Directions
  • adults and children 12 years of age and older: apply at least a 1-inch strip of the product onto a soft bristled toothbrush. Brush teeth thoroughly for at least 1 minute twice a day (morning and evening) or as recommended by a dentist. Make sure to brush all sensitive areas of the teeth.
  • do not swallow.
  • children under 12 years of age: consult a dentist.
Questions?

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

Active Ingredient (Active ingredient)

Stannous Fluoride 0.454% (0.15% w/v fluoride ion)

Other Information
  • products containing stannous fluoride may produce surface staining of the teeth. Adequate toothbrushing may prevent these stains which are not harmful or permanent and may be removed by your dentist.
  • this Hello product is specially formulated to help prevent staining.
Inactive Ingredients (Inactive ingredients)

water, sorbitol, hydrated silica, glycerin, xylitol, tetrasodium pyrophosphate, flavor, zinc phosphate, sodium citrate, cellulose gum, sodium cocoyl glutamate, cocamidopropyl betaine, xanthan gum, rebaudioside a, citric acid.

Stop Use and Ask A Dentist If (Stop use and ask a dentist if)
  • gingivitis, bleeding, or redness persists for more than 2 weeks.
  • you have painful or swollen gums, pus from the gum line, loose teeth, or increasing spacing between the teeth. These may be signs of periodontitis, a serious form of gum disease.
Principal Display Panel 113 G Tube Carton (PRINCIPAL DISPLAY PANEL - 113 g Tube Carton)

hello®

8 in 1

mighty multi-tasker

fluoride toothpaste

for anticavity, antigingivitis + antisensitivity

natural mint blend

NET WT 4.0 OZ (113 g)


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)