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

labelhello
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 TypeHUMAN OTC DRUGItem Code (Source)NDC: 44038-0680
Route of AdministrationDENTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION1.1 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
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    
ShapeSize
FlavorORANGEImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 44038-0680-11 in 1 CARTON07/01/2023
1119 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02107/01/2023
Labeler - Accupac LLC (071609663)
Registrant - Accupac LLC (061595175)
Establishment
NameAddressID/FEIBusiness Operations
Accupac LLC061595175manufacture(44038-0680)

Revised: 9/2024
 

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