Hello Juicy Grape Fluoride: Package Insert and Label Information

HELLO JUICY GRAPE FLUORIDE- sodium fluoride paste, dentifrice
Hello Products LLC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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.

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 years: use only a pea sized amount and supervise child’s brushing and rinsing (to minimize swallowing)
  • children under 2 years: ask a dentist or a physician.

Inactive ingredients

sorbitol, hydrated silica, purified water, glycerin, xylitol, xanthan gum, flavor, titanium dioxide, cocamidopropyl betaine, sodium cocoyl glutamate and stevia rebaudiana leaf extract 1.


1
certified organic

Questions?

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

Distributed by Hello Products LLC Montclair, NJ 07042

PRINCIPAL DISPLAY PANEL — 119 g Tube Box

naturally
friendly

hello®

fluoride toothpaste
kids ages 2+

juicy grape
natural flavor

prevents cavities
polishes + brightens
strengthens enamel
tastes awesome

not tested
on animals

vegan. no artificial sweeteners. no dyes.
no SLS/sulfates. no brainer.

NET WT 4.2 OZ (119 g)

PRINCIPAL DISPLAY PANEL -- 119 g Tube Box
(click image for full-size original)
HELLO JUICY GRAPE FLUORIDE
sodium fluoride paste, dentifrice
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:55882-6112
Route of Administration DENTAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SODIUM FLUORIDE (FLUORIDE ION) FLUORIDE ION 1.5 mg in 1 g
Inactive Ingredients
Ingredient Name Strength
SORBITOL
HYDRATED SILICA
WATER
GLYCERIN
XYLITOL
XANTHAN GUM
TITANIUM DIOXIDE
COCAMIDOPROPYL BETAINE
SODIUM COCOYL GLUTAMATE
STEVIA REBAUDIUNA LEAF
Product Characteristics
Color WHITE Score
Shape Size
Flavor GRAPE Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:55882-6112-1 1 TUBE in 1 BOX contains a TUBE
1 113 g in 1 TUBE This package is contained within the BOX (55882-6112-1)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC MONOGRAPH FINAL part355 03/01/2021 12/31/2024
Labeler — Hello Products LLC (040714890)
Establishment
Name Address ID/FEI Operations
Lornamead 080046418 MANUFACTURE (55882-6112)

Revised: 03/2023 Hello Products LLC

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