Hello Vitamin C Whitening by Accupac LLC

Hello Vitamin C Whitening by

Drug Labeling and Warnings

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

Drug Details [pdf]

HELLO VITAMIN C WHITENING- sodium fluoride paste, dentifrice 
Accupac LLC

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Hello Vitamin C Whitening

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 physician.

Inactive ingredients

water, hydrated silica, sorbitol, glycerin, xylitol, pentasodium triphosphate,
tetrapotassium pyrophosphate, sodium ascorbyl phosphate (vitamin c), flavor, cellulose
gum, sodium cocoyl glutamate, cocamidopropyl betaine, xanthan gum, rebaudioside a,
annatto 1

1 natural annatto pigment provides orange color

Questions?

855-HI-HELLO (1-855-444-3556)
Dist. by Colgate-Palmolive Co.
New York, NY 10022

PRINCIPAL DISPLAY PANEL - 113 g Tube Carton

hello
vitamin c
whitening
2 shades whiter*
C the
sparkle
natural peppermint
anticavity fluoride toothpaste
NET WT 4.0 OZ (113 g)

HELLO VITAMIN C WHITENING 
sodium fluoride paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 44038-0689
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	SODIUM FLUORIDE	1.5 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
HYDRATED SILICA (UNII: Y6O7T4G8P9)
REBAUDIOSIDE A (UNII: B3FUD0528F)
XYLITOL (UNII: VCQ006KQ1E)
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED (UNII: K679OBS311)
GLYCERIN (UNII: PDC6A3C0OX)
ANNATTO (UNII: 6PQP1V1B6O)
SODIUM ASCORBYL PHOSPHATE (UNII: 836SJG51DR)
SORBITOL (UNII: 506T60A25R)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
XANTHAN GUM (UNII: TTV12P4NEE)
SODIUM TRIPOLYPHOSPHATE ANHYDROUS (UNII: 9SW4PFD2FZ)
SODIUM COCOYL GLUTAMATE (UNII: BMT4RCZ3HG)
WATER (UNII: 059QF0KO0R)
SODIUM PYROPHOSPHATE (UNII: O352864B8Z)

Product Characteristics
Color	orange	Score
Shape		Size
Flavor	PEPPERMINT	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 44038-0689-1	1 in 1 CARTON	07/01/2023
1		113 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 (061595715)

Establishment
Name	Address	ID/FEI	Business Operations
Accupac LLC		061595175	manufacture(44038-0689)

Revised: 10/2024

Document Id: 23f9e79c-b61f-51f2-e063-6394a90a9609

34390-5

Set id: 23f763d1-8ef5-0c1f-e063-6394a90ac425

Version: 2

Effective Time: 20241008