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

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. Do not use if the 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: Use a pea sized amount and supervise until good brushing habits are established to minimize swallowing.
• Children under 2: Ask a dentist.

Inactive Ingredients

Sorbitol, Hydrated Silica, Vegetable Glycerin, Purified Water, Xylitol, Natural and Artificial Flavor, Xanthan Gum, Sodium Lauryl Sulfate, Titanium Dioxide and Stevia.

Questions?

855-HI-HELLO

SPL UNCLASSIFIED SECTION

Distributed by Hello Products LLC Montclair, NJ 07042

PRINCIPAL DISPLAY PANEL - 177 g Bottle Label - supermint

99%
natural

hello™

anticavity toothpaste
strengthens+whitens teeth

supermint

NET WT 6.25OZ (177g)

PRINCIPAL DISPLAY PANEL - 177 g Bottle Label - sweet cinnamint

99%
natural

hello™

anticavity toothpaste
strengthens+whitens teeth

sweet cinnamint

NET WT 6.25OZ (177g)

PRINCIPAL DISPLAY PANEL - 177 g Bottle Label - mojito mint

99%
natural

hello™

anticavity toothpaste
strengthens+whitens teeth

mojito mint

NET WT 6.25OZ (177g)

PRINCIPAL DISPLAY PANEL - 177 g Bottle Label - pink grapefruit mint

99%
natural

hello™

anticavity toothpaste
strengthens+whitens teeth

pink grapefruit mint

NET WT 6.25OZ (177g)

INGREDIENTS AND APPEARANCE

HELLO 
sodium fluoride paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55882-6011
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	MINT (Supermint)	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 55882-6011-1	177 g in 1 BOTTLE, DISPENSING

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part355	03/04/2013

HELLO 
sodium fluoride paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55882-6013
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	CINNAMON (Sweet Cinnamint)	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 55882-6013-1	177 g in 1 BOTTLE, DISPENSING

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part355	03/04/2013

HELLO 
sodium fluoride paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55882-6012
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	LIME (Mojito Mint)	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 55882-6012-1	177 g in 1 BOTTLE, DISPENSING

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part355	03/04/2013

HELLO 
sodium fluoride paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55882-6014
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	GRAPEFRUIT (Pink Grapefruit Mint)	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 55882-6014-1	177 g in 1 BOTTLE, DISPENSING

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part355	03/04/2013

Labeler - Hello Products LLC (040714890)

Establishment
Name	Address	ID/FEI	Business Operations
Accupac, Inc.		071609663	MANUFACTURE(55882-6011, 55882-6013, 55882-6012, 55882-6014)