Hellounicorn splash anticavity fluoride rinse

Hello by

Drug Labeling and Warnings

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

Drug Details [pdf]

HELLO  UNICORN SPLASH ANTICAVITY FLUORIDE RINSE- sodium fluoride mouthwash 
Hello Products LLC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Hello
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 swish 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

Dist. by Hello Products LLC
Montclair, NJ 07042

PRINCIPAL DISPLAY PANEL - 473 mL Bottle Label

naturally
friendly™
hello®

unicorn splash
anticavity fluoride rinse

bubble gum
natural flavor

prevents cavities
no alcohol
strengthens teeth

tastes magical
works brilliantly

no artificial sweeteners. no dyes.
no SLS/sulfates. no brainer.

16 FL OZ (1 PT) 473 mL

44917

HELLO   UNICORN SPLASH ANTICAVITY FLUORIDE RINSE
sodium fluoride mouthwash

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55882-6118
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: 55882-6118-1	473 mL in 1 BOTTLE; Type 0: Not a Combination Product	01/03/2022	07/01/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part355	01/03/2022	07/01/2023

Labeler - Hello Products LLC (040714890)

Establishment
Name	Address	ID/FEI	Business Operations
Accupac		071609663	MANUFACTURE(55882-6118)

Revised: 7/2023

Document Id: 268f169c-5a57-4686-90b3-9f6230958db1

34390-5

Set id: 892ce4d4-85d1-4a03-b231-8adb65990f4f

Version: 2

Effective Time: 20230701