HELLO- sodium fluoride paste, dentifrice

Hello by

Drug Labeling and Warnings

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

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredient

Sodium fluoride 0.24%
(0.15% w/v fluoride ion)

Purpose

Anticavity

Use

Aids in the prevention of dental 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.

Twist off cap to remove foil seal.

Do not use if safety seal is missing or broken.

Directions

• Adults and children 2 years of age and older: Brush teeth thoroughly, preferably after each meal or at least twice per day, or as directed by a dentist or physician.
• Do not swallow.
• Children under 6 years of age: Use a pea-sized amount and supervise until good brushing habits are established to minimize swallowing.
• Children under 2 years of age: Consult a dentist or physician.

Inactive Ingredients

Sorbitol, Hydrated Silica, Glycerin, Purified Water, Xylitol, Flavor, Xanthan Gum, Sodium Lauryl Sulfate, Titanium Dioxide and Stevia Rebaudiana Leaf Extract.

Questions?

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

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Distributed by Hello Products LLC Montclair, NJ 07042

PRINCIPAL DISPLAY PANEL - 142 g Tube Box - Peach Mango Mint

hello®

fluoride toothpaste

prevents cavities, strengthens enamel,
polishes teeth + freshens breath

peach mango mint

NET WT 5OZ (142g)

PRINCIPAL DISPLAY PANEL - 119 g Tube Box - Bubble Gum

hello®

naturally
friendly™

kids

fluoride toothpaste

prevents cavities, polishes teeth
+ strengthens enamel

bubble gum

NET WT 4.2OZ (119g)

PRINCIPAL DISPLAY PANEL - 119 g Tube Box - Green Apple

hello®

naturally
friendly™

kids

fluoride toothpaste

prevents cavities, polishes teeth
+ strengthens enamel

green apple

NET WT 4.2OZ (119g)

PRINCIPAL DISPLAY PANEL - 119 g Tube Box - Blue Raspberry

hello®

naturally
friendly™

kids

fluoride toothpaste

prevents cavities, polishes teeth
+ strengthens enamel

blue raspberry

NET WT 4.2OZ (119g)

INGREDIENTS AND APPEARANCE

HELLO 
sodium fluoride paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55882-6092
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Sodium fluoride (UNII: 8ZYQ1474W7) (fluoride ion - UNII:Q80VPU408O)	fluoride ion	1.5 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
Sorbitol (UNII: 506T60A25R)
Hydrated Silica (UNII: Y6O7T4G8P9)
Glycerin (UNII: PDC6A3C0OX)
Water (UNII: 059QF0KO0R)
Xylitol (UNII: VCQ006KQ1E)
Xanthan Gum (UNII: TTV12P4NEE)
Sodium Lauryl Sulfate (UNII: 368GB5141J)
Titanium Dioxide (UNII: 15FIX9V2JP)
Stevia Rebaudiuna Leaf (UNII: 6TC6NN0876)

Product Characteristics
Color	WHITE	Score
Shape		Size
Flavor	PEACH, MANGO, MINT	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 55882-6092-1	1 in 1 BOX
1		142 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 FINAL	part355	03/01/2015

HELLO 
sodium fluoride paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55882-6093
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Sodium fluoride (UNII: 8ZYQ1474W7) (fluoride ion - UNII:Q80VPU408O)	fluoride ion	1.5 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
Sorbitol (UNII: 506T60A25R)
Hydrated Silica (UNII: Y6O7T4G8P9)
Glycerin (UNII: PDC6A3C0OX)
Water (UNII: 059QF0KO0R)
Xylitol (UNII: VCQ006KQ1E)
Xanthan Gum (UNII: TTV12P4NEE)
Sodium Lauryl Sulfate (UNII: 368GB5141J)
Titanium Dioxide (UNII: 15FIX9V2JP)
Stevia Rebaudiuna Leaf (UNII: 6TC6NN0876)

Product Characteristics
Color	WHITE	Score
Shape		Size
Flavor	BUBBLE GUM	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 55882-6093-1	1 in 1 BOX
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 FINAL	part355	03/01/2015

HELLO 
sodium fluoride paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55882-6094
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Sodium fluoride (UNII: 8ZYQ1474W7) (fluoride ion - UNII:Q80VPU408O)	fluoride ion	1.5 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
Sorbitol (UNII: 506T60A25R)
Hydrated Silica (UNII: Y6O7T4G8P9)
Glycerin (UNII: PDC6A3C0OX)
Water (UNII: 059QF0KO0R)
Xylitol (UNII: VCQ006KQ1E)
Xanthan Gum (UNII: TTV12P4NEE)
Sodium Lauryl Sulfate (UNII: 368GB5141J)
Titanium Dioxide (UNII: 15FIX9V2JP)
Stevia Rebaudiuna Leaf (UNII: 6TC6NN0876)

Product Characteristics
Color	WHITE	Score
Shape		Size
Flavor	APPLE (Green Apple)	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 55882-6094-1	1 in 1 BOX
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 FINAL	part355	03/01/2015

HELLO 
sodium fluoride paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55882-6095
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Sodium fluoride (UNII: 8ZYQ1474W7) (fluoride ion - UNII:Q80VPU408O)	fluoride ion	1.5 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
Sorbitol (UNII: 506T60A25R)
Hydrated Silica (UNII: Y6O7T4G8P9)
Glycerin (UNII: PDC6A3C0OX)
Water (UNII: 059QF0KO0R)
Xylitol (UNII: VCQ006KQ1E)
Xanthan Gum (UNII: TTV12P4NEE)
Sodium Lauryl Sulfate (UNII: 368GB5141J)
Titanium Dioxide (UNII: 15FIX9V2JP)
Stevia Rebaudiuna Leaf (UNII: 6TC6NN0876)

Product Characteristics
Color	WHITE	Score
Shape		Size
Flavor	RASPBERRY (Blue Raspberry)	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 55882-6095-1	1 in 1 BOX
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 FINAL	part355	03/01/2015

Labeler - Hello Products LLC (040714890)

Establishment
Name	Address	ID/FEI	Business Operations
Accupac, Inc.		071609663	MANUFACTURE(55882-6092, 55882-6093, 55882-6094, 55882-6095)