HELLO NATURALLY WHITENING- sodium monofluorophosphate paste, dentifrice

Hello Naturally Whitening by

Drug Labeling and Warnings

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

Drug Details [pdf]

Hello Naturally Whitening

Drug facts

Active ingredient

Sodium monofluorophosphate 0.76% (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 Poison Control 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 physician

Inactive Ingredients

glycerin, water, hydrated silica, calcium carbonate, sorbitol, erythritol, xylitol, flavor, xanthan gum, sodium bicarbonate, potassium citrate, sodium cocoyl glutamate, cocamidopropyl betaine, cocos nucifera (coconut) oil, rebaudioside a 1, melaleuca alternifolia (tea tree) leaf oil.

1 certified organic

Questions?

855-HI-HELLO (1-855-444-3556)
Distributed by Hello Products LLC
Montclair, NJ 07042

SPL UNCLASSIFIED SECTION

PRINCIPAL DISPLAY PANEL - 133 g Tube Carton

naturally
friendly
hello
naturally
whitening*
anticavity
fluoride toothpaste
mint
to be
farm grown mint + coconut oil
NET WT 4.7 OZ (133 g)

INGREDIENTS AND APPEARANCE

HELLO NATURALLY WHITENING 
sodium monofluorophosphate paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 44038-0682
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM MONOFLUOROPHOSPHATE (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	1.1 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
CALCIUM CARBONATE (UNII: H0G9379FGK)
SORBITOL (UNII: 506T60A25R)
XANTHAN GUM (UNII: TTV12P4NEE)
SODIUM BICARBONATE (UNII: 8MDF5V39QO)
POTASSIUM CITRATE (UNII: EE90ONI6FF)
TEA TREE OIL (UNII: VIF565UC2G)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
XYLITOL (UNII: VCQ006KQ1E)
COCONUT OIL (UNII: Q9L0O73W7L)
HYDRATED SILICA (UNII: Y6O7T4G8P9)
GLYCERIN (UNII: PDC6A3C0OX)
WATER (UNII: 059QF0KO0R)
ERYTHRITOL (UNII: RA96B954X6)
SODIUM COCOYL GLUTAMATE (UNII: BMT4RCZ3HG)
REBAUDIOSIDE A (UNII: B3FUD0528F)

Product Characteristics
Color	white	Score
Shape		Size
Flavor	MINT	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 44038-0682-1	1 in 1 CARTON	07/01/2023
1		133 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 Drug	M021	07/01/2023

Labeler - Accupac LLC (071609663)

Registrant - Accupac LLC (061595175)

Establishment
Name	Address	ID/FEI	Business Operations
Accupac LLC		061595175	manufacture(44038-0682)