Hello

Manufacturer
Colgate-Palmolive Company | Accupac
Effective date
2026-06-02
Label type
HUMAN OTC DRUG LABEL
Version
10
Source
daily-update
Hydrated at
2026-06-06 05:10:08

Label at a glance#

ProductHello Unicorn Splash unicorn splash anticavity fluoride rinse
Active ingredientSODIUM FLUORIDE
Label structure11 sections

Dosage and administration

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 us...

Storage and handling

store at room temperature do not use if printed band around cap is broken or missing

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

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

Purpose

OTC - PURPOSE SECTION

Anticavity

Use

INDICATIONS & USAGE SECTION

aids in the prevention of dental cavities.

Warnings

WARNINGS SECTION

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

DOSAGE & ADMINISTRATION SECTION

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

Other information

STORAGE AND HANDLING SECTION

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

Inactive ingredients

INACTIVE INGREDIENT SECTION

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

Questions?

OTC - QUESTIONS SECTION

1-855-444-3556

SPL UNCLASSIFIED SECTION

Dist. by Colgate-Palmolive Co.
New York, NY 10022

PRINCIPAL DISPLAY PANEL - 520 mL Bottle Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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.

PRINCIPAL DISPLAY PANEL - 520 mL Bottle Label
PRINCIPAL DISPLAY PANEL - 520 mL Bottle Label

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
Data codeData Matrix0086273hellounicorn-01.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
35000-68735000-687-10, 35000-687-12

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
82025-11-10full-release2026-06-01 01:43:11
72025-04-16full-release2026-06-01 00:59:19

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Hello Unicorn Splash unicorn splash anticavity fluoride rinseSODIUM FLUORIDEColgate-Palmolive Companya1014431-7d23-aaff-6dc7-ab58683d03382026-06-02WarningsExact identifier
ndc (package): 35000-687-10
ndc (package): 35000-687-12
ndc (product): 35000-687
ndc11 (package): 35000068712
ndc11 (package): 35000068710
spl id: 5ad12666-22b6-4760-894f-8d9e96f41714
spl set id: a1014431-7d23-aaff-6dc7-ab58683d0338

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.