HELLO VITAMIN C WHITENING- sodium fluoride paste, dentifrice

Hello Vitamin C Whitening by

Drug Labeling and Warnings

Hello Vitamin C Whitening by is a Otc medication manufactured, distributed, or labeled by Colgate-Palmolive Company. 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.

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
• chldren 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, annatto1.

1 natural annatto pigment provides orange color

Questions?

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

SPL UNCLASSIFIED SECTION

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)

INGREDIENTS AND APPEARANCE

HELLO VITAMIN C WHITENING 
sodium fluoride paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 35000-689
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
WATER (UNII: 059QF0KO0R)
HYDRATED SILICA (UNII: Y6O7T4G8P9)
SORBITOL (UNII: 506T60A25R)
GLYCERIN (UNII: PDC6A3C0OX)
XYLITOL (UNII: VCQ006KQ1E)
SODIUM TRIPOLYPHOSPHATE ANHYDROUS (UNII: 9SW4PFD2FZ)
SODIUM PYROPHOSPHATE (UNII: O352864B8Z)
SODIUM ASCORBYL PHOSPHATE (UNII: 836SJG51DR)
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED (UNII: K679OBS311)
SODIUM COCOYL GLUTAMATE (UNII: BMT4RCZ3HG)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
XANTHAN GUM (UNII: TTV12P4NEE)
REBAUDIOSIDE A (UNII: B3FUD0528F)
ANNATTO (UNII: 6PQP1V1B6O)

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: 35000-689-10	1 in 1 CARTON	01/01/2024
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	01/01/2024

Labeler - Colgate-Palmolive Company (001344381)