Hello Magical Mermaid by Accupac LLC

Hello Magical Mermaid by

Drug Labeling and Warnings

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

Drug Details [pdf]

HELLO MAGICAL MERMAID- sodium fluoride gel, dentifrice 
Accupac LLC

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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 yearsuse only a pea sized amount and supervise child's brushing and rinsing (to minimize swallowing)-

children 2 and under-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

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: 44038-0680
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
ERYTHRITOL (UNII: RA96B954X6)
LAURYL GLUCOSIDE (UNII: 76LN7P7UCU)
XANTHAN GUM (UNII: TTV12P4NEE)
POTASSIUM CITRATE (UNII: EE90ONI6FF)
SODIUM PYROPHOSPHATE (UNII: O352864B8Z)
HYDRATED SILICA (UNII: Y6O7T4G8P9)
XYLITOL (UNII: VCQ006KQ1E)
REBAUDIOSIDE A (UNII: B3FUD0528F)
WATER (UNII: 059QF0KO0R)
SODIUM BICARBONATE (UNII: 8MDF5V39QO)
GLYCERIN (UNII: PDC6A3C0OX)
SORBITOL (UNII: 506T60A25R)

Product Characteristics
Color		Score
Shape		Size
Flavor	ORANGE	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 44038-0680-1	1 in 1 CARTON	07/01/2023
1		119 g in 1 TUBE; Type 0: Not a Combination Product

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(44038-0680)

Revised: 9/2024

Document Id: 22de548e-b776-378d-e063-6394a90ab23e

34390-5

Set id: 22de548e-b775-378d-e063-6394a90ab23e

Version: 1

Effective Time: 20240924