Hello Magical Mermaid by Hello Products LLC / Lornamead Hello® Magical Mermaid

Hello Magical Mermaid by

Drug Labeling and Warnings

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

Drug Details [pdf]

HELLO MAGICAL MERMAID- sodium fluoride gel, dentifrice 
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® Magical Mermaid

Drug Facts

Active Ingredient

Sodium fluoride 0.24% (0.14% w/v fluoride ion)

Purpose

Anticavity

Use

helps protect against cavities

Warnings

Keep out of reach of children under 6 years of age.

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

Directions

• adults and children 2 years of age and older: brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or physician
• children 2 to 6 years: use only a pea sized amount and supervise child's brushing and rinsing (to minimize swallowing)
• children under 2 years: ask a dentist or physician

Inactive ingredients

glycerin, sorbitol, water, hydrated silica, erythritol, xylitol, xanthan gum, sodium bicarbonate, lauryl glucoside, potassium citrate, tetrasodium pyrophosphate, rebaudioside a, flavor.

Questions?

855-HI-HELLO (1-855-444-3556)

Dist. by Hello Products LLC Montclair, NJ 07042

PRINCIPAL DISPLAY PANEL - 119 g Tube Label

hello®
magical mermaid
anticavity fluoride toothpaste

tastes magical
works brilliantly

orange dreamsicle

natural flavor

NET WT 4.2 OZ (119 g)

HELLO MAGICAL MERMAID 
sodium fluoride gel, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55882-6210
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	1.1 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)
SORBITOL (UNII: 506T60A25R)
WATER (UNII: 059QF0KO0R)
HYDRATED SILICA (UNII: Y6O7T4G8P9)
ERYTHRITOL (UNII: RA96B954X6)
XYLITOL (UNII: VCQ006KQ1E)
XANTHAN GUM (UNII: TTV12P4NEE)
SODIUM BICARBONATE (UNII: 8MDF5V39QO)
LAURYL GLUCOSIDE (UNII: 76LN7P7UCU)
POTASSIUM CITRATE (UNII: EE90ONI6FF)
SODIUM PYROPHOSPHATE (UNII: O352864B8Z)
REBAUDIOSIDE A (UNII: B3FUD0528F)

Product Characteristics
Color		Score
Shape		Size
Flavor	ORANGE	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 55882-6210-1	119 g in 1 TUBE; Type 0: Not a Combination Product	12/13/2022	07/01/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part355	12/13/2022	07/01/2023

Labeler - Hello Products LLC (040714890)

Establishment
Name	Address	ID/FEI	Business Operations
Lornamead		080046418	MANUFACTURE(55882-6210)

Revised: 12/2022

Document Id: 233aa512-ced9-451e-97c5-f35724215c4a

34390-5

Set id: de72acb8-6e4a-d72e-2c3a-c413ee7e7e98

Version: 4

Effective Time: 20221213