HELLO BUBBLE GUM - SLS FREE- sodium fluoride paste, dentifrice

Hello by

Drug Labeling and Warnings

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

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active ingredient

Sodium fluoride 0.24%

(0.15% w/v fluoride ion)

PURPOSE

Purpose

Anticavity

INDICATIONS & USAGE

Use

Helps protect against cavities.

WARNINGS

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.

DOSAGE & ADMINISTRATION

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 INGREDIENT

Inactive Ingredients

Sorbitol, Hydrated Silica, Purified Water, Glycerin, Xylitol, Flavor, Xanthan Gum, Titanium Dioxide,Cocamidopropyl Betaine, Sodium Cocoyl Glutamate and Stevia Rebaudiana Leaf Extract.

QUESTIONS

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

SPL UNCLASSIFIED SECTION

Distributed by Hello Products LLC Montclair, NJ 07042

©2017 Hello Products LLC, www.helloproducts.com

PRINCIPAL DISPLAY PANEL

naturally friendly™

hello® bubblegum

fluoride toothpaste

prevents cavities

strengthens enamel

tastes awesome

polishes + brightens

no artificial sweeteners. no dyes. no preservatives. no SLS/sulfates.

kids ages 2+

NET WT 4.2 OZ (119g)

INGREDIENTS AND APPEARANCE

HELLO  BUBBLE GUM - SLS FREE
sodium fluoride paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55882-6025
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	SODIUM FLUORIDE	0.24 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
HYDRATED SILICA (UNII: Y6O7T4G8P9)
GLYCERIN (UNII: PDC6A3C0OX)
XYLITOL (UNII: VCQ006KQ1E)
XANTHAN GUM (UNII: TTV12P4NEE)
SODIUM COCOYL GLUTAMATE (UNII: BMT4RCZ3HG)
STEVIA REBAUDIUNA LEAF (UNII: 6TC6NN0876)
SORBITOL (UNII: 506T60A25R)
WATER (UNII: 059QF0KO0R)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 55882-6025-1	1 in 1 CARTON	04/01/2018
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	04/01/2018

Labeler - Hello Products LLC (040714890)

Establishment
Name	Address	ID/FEI	Business Operations
Lornamead Inc.		078584069	manufacture(55882-6025)