THE NATURAL DENTIST WHITENING- fluoride paste, dentifrice

The Natural Dentist by

Drug Labeling and Warnings

The Natural Dentist by is a Otc medication manufactured, distributed, or labeled by Caldwell Consumer Health, LLC, Goran Pharma Private Limited. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

Sodium fluoride (0.24%) (0.15% w/v fluoride ion)

Purpose

Purpose: Anticavity

INDICATIONS & USAGE

Use

Aids in the prevention of dental cavities

WARNINGS

Warnings

Keep out of reach of children under 6 years of age. If more than used for brushing is accidentily swallowed, get medical help or contact a Poison Control Center right away. Do not use if the safety seal is missing or broken.

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

Hydrated silica, vegetable glycerin, sorbitol, water, xylitol, cocamidopropyl betaine, sodium cocoyl glycinate, Aloe barbadensis leaf juice, cellulose gum, Citrus grandis (grapefruit) seed extract, titanium dioxide, xanthan gum, flavor.

Other Information

Store standing up with cap tightly closed.

QUESTIONS: Call 1-888-317-4402, weekdays 9 to 5 EST.

TheNaturalDentist.com

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

THE NATURAL DENTIST  WHITENING
fluoride paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 34362-0232
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	0.2430 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)
HYDRATED SILICA (UNII: Y6O7T4G8P9)
WATER (UNII: 059QF0KO0R)
XYLITOL (UNII: VCQ006KQ1E)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
CARBOXYMETHYLCELLULOSE (UNII: 05JZI7B19X)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
ECHINACEA ANGUSTIFOLIA (UNII: VB06AV5US8)
GOLDENSEAL (UNII: ZW3Z11D0JV)
CALENDULA OFFICINALIS WHOLE (UNII: PFR03EBU0H)
XANTHAN GUM (UNII: TTV12P4NEE)
CITRIC ACID ACETATE (UNII: DSO12WL7AU)
ZINC CITRATE (UNII: K72I3DEX9B)
GRAPEFRUIT SEED OIL (UNII: 598D944HOL)

Product Characteristics
Color	white (light Off White)	Score
Shape		Size
Flavor	CINNAMON (Cinnamon Mint)	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 34362-0232-1	142 g in 1 TUBE; Type 0: Not a Combination Product	05/01/2011

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part355	05/01/2011

Labeler - Caldwell Consumer Health, LLC (828558713)

Establishment
Name	Address	ID/FEI	Business Operations
Goran Pharma Private Limited		828558713	manufacture(34362-0232) , pack(34362-0232)