HELLO UNICORN SPLASH UNICORN SPLASH ANTICAVITY FLUORIDE RINSE- sodium fluoride mouthwash

Hello Unicorn Splash by

Drug Labeling and Warnings

Hello Unicorn Splash by is a Otc medication manufactured, distributed, or labeled by Colgate-Palmolive Company. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

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 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

• 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

SPL UNCLASSIFIED SECTION

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

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  UNICORN SPLASH ANTICAVITY FLUORIDE RINSE
sodium fluoride mouthwash

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 35000-687
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)
XYLITOL (UNII: VCQ006KQ1E)
SODIUM PHOSPHATE, MONOBASIC, ANHYDROUS (UNII: KH7I04HPUU)
POLOXAMER 407 (UNII: TUF2IVW3M2)
POTASSIUM CITRATE (UNII: EE90ONI6FF)
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: 35000-687-10	473 mL in 1 BOTTLE; Type 0: Not a Combination Product	07/01/2023	11/30/2027
2	NDC: 35000-687-12	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 - Colgate-Palmolive Company (001344381)

Registrant - Accupac (061595175)