Hello®

Hello®
SPL v8
SPL
SPL Set ID a1014431-7d23-aaff-6dc7-ab58683d0338
Route
DENTAL
Published
Effective Date 2025-11-10
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Fluoride Ion (0.02 g)
Inactive Ingredients
Water Glycerin Xylitol Sodium Phosphate, Monobasic, Anhydrous Poloxamer 407 Potassium Citrate Phosphoric Acid

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Completed Since 2023-07-01 Until 2027-11-30
Description

Drug Facts

Purpose

Anticavity

Medication Information

Purpose

Anticavity

Description

Drug Facts

Use

aids in the prevention of dental cavities.

Section 42229-5

Drug Facts

Section 50565-1

Keep out of reach of children.

If more than used for rinsing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

Directions

Adults and children 6 years of age and older:

  • Use once a day after brushing your teeth with a toothpaste
  • vigorously swith 10 mL (2 teaspoonfuls) of rinse between your teeth for 1 minute and then spit out
  • do not swallow the rinse
  • do not eat or drink for 30 minutes after rinsing
  • instruct children under 12 years of age in good rinsing habits (to minimize swallowing)
  • supervise children as necessary until capable of using without supervision

Children under 6 years of age: consult a dentist or doctor

Questions?

1-855-444-3556

Active Ingredient

Sodium Fluoride 0.05% (0.02% w/v fluoride ion)

Other Information
  • store at room temperature
  • do not use if printed band around cap is broken or missing
Inactive Ingredients

purified water, vegetable glycerin, xylitol, sodium phosphate monobasic, flavor, poloxamer 407, potassium citrate, phosphoric acid

Principal Display Panel 520 Ml Bottle Label

hello®

unicorn splash

anticavity fluoride rinse

bubble gum

natural flavor

prevents cavities • no alcohol

strengthens teeth

17.6 FL OZ (1.1 PT) 520 mL

PS0086273

IMPORTANT:

Read directions

for proper use.

Structured Label Content

Use

aids in the prevention of dental cavities.

Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

Keep out of reach of children.

If more than used for rinsing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

Purpose

Anticavity

Directions

Adults and children 6 years of age and older:

  • Use once a day after brushing your teeth with a toothpaste
  • vigorously swith 10 mL (2 teaspoonfuls) of rinse between your teeth for 1 minute and then spit out
  • do not swallow the rinse
  • do not eat or drink for 30 minutes after rinsing
  • instruct children under 12 years of age in good rinsing habits (to minimize swallowing)
  • supervise children as necessary until capable of using without supervision

Children under 6 years of age: consult a dentist or doctor

Questions?

1-855-444-3556

Active Ingredient (Active ingredient)

Sodium Fluoride 0.05% (0.02% w/v fluoride ion)

Other Information (Other information)
  • store at room temperature
  • do not use if printed band around cap is broken or missing
Inactive Ingredients (Inactive ingredients)

purified water, vegetable glycerin, xylitol, sodium phosphate monobasic, flavor, poloxamer 407, potassium citrate, phosphoric acid

Principal Display Panel 520 Ml Bottle Label (PRINCIPAL DISPLAY PANEL - 520 mL Bottle Label)

hello®

unicorn splash

anticavity fluoride rinse

bubble gum

natural flavor

prevents cavities • no alcohol

strengthens teeth

17.6 FL OZ (1.1 PT) 520 mL

PS0086273

IMPORTANT:

Read directions

for proper use.

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:05:55.711993 · Updated: 2026-03-14T23:13:34.159935