HELLO UNICORN SPLASH- sodium fluoride mouthwash

Hello Unicorn Splash by

Drug Labeling and Warnings

Hello Unicorn Splash by is a Otc medication manufactured, distributed, or labeled by Accupac LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Hello Unicorn Splash unicorn splash anticavity fluoride rinse

Drug Facts

Active ingredient

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

Purpose

Anticavity

Use

aids in the prevention of dental cavities.

Warnings

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 teaspoons) 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).

Surpervise children as necessary until capable of using without supervision.

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

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.

Questions?

1-855-444-3556

Dist. by Hello Products LLC

Montclair, NJ 07042

SPL UNCLASSIFIED SECTION

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.

INGREDIENTS AND APPEARANCE

HELLO UNICORN SPLASH 
sodium fluoride mouthwash

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 44038-0687
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	0.02 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
SODIUM PHOSPHATE, MONOBASIC, ANHYDROUS (UNII: KH7I04HPUU)
POTASSIUM CITRATE (UNII: EE90ONI6FF)
XYLITOL (UNII: VCQ006KQ1E)
POLOXAMER 407 (UNII: TUF2IVW3M2)
PHOSPHORIC ACID (UNII: E4GA8884NN)

Product Characteristics
Color		Score
Shape		Size
Flavor	BUBBLE GUM	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 44038-0687-1	473 mL in 1 BOTTLE; Type 0: Not a Combination Product	07/01/2023	11/30/2027
2	NDC: 44038-0687-2	520 mL in 1 BOTTLE; Type 0: Not a Combination Product	01/01/2026

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M021	07/01/2023

Labeler - Accupac LLC (071609663)

Registrant - Accupac LLC (061595175)

Establishment
Name	Address	ID/FEI	Business Operations
Accupac LLC		061595175	manufacture(44038-0687)