THE NATURAL DENTIST CHARCOAL WHITENING FLUORIDE- sodium 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 Health LLC, GORAN PHARMA PRIVATE LIMITED. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

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. If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away. Do not use if the safety seal is missing or broken.

DOSAGE & ADMINISTRATION

Directions

• Adults and children 2 years of age and older: Brush teeh thoroughly, preferably after each meal or at least twice 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.

STORAGE AND HANDLING

Other information

Store standing up with cap tightly closed.

INACTIVE INGREDIENT

Inactive ingredients Sorbitol, hydrated silica, glycerin, xylitol, water, charcoal powder, cocamidopropyl betaine, sodium cocoyl glycinate, flavor, cellulose gum, xanthan gum, Citrus grandis (grapefruit) seed extract, Aloe barbadensis leaf juice.

QUESTIONS

Questions?

Call 1-888-317-4402, weekdays 9 to 5 ET.

SPL UNCLASSIFIED SECTION

Manufactured for Revive Personal Products Company,

Madison, NJ 07940

© 2018 Revive Personal Products Company.

Made in USA. Vegan. Not tested on animals.

PRINCIPAL DISPLAY PANEL

NO SLS! NEW!

THE NATURAL DENTIST

CHARCOAL WHITENING FLUORIDE TOOTHPASTE

with ACTIVATED CHARCOAL

• Prevents Cavities
• Whitens Teeth
• Strengthens Tooth Enamel
• Removes Stains
• Freshens Breath

Safe for Everyday Use

COCOMINT™ FLAVOR

No artificial flavors or colors.

NET WT 5.0 OZ (141 g)

INGREDIENTS AND APPEARANCE

THE NATURAL DENTIST  CHARCOAL WHITENING FLUORIDE
sodium fluoride paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 34362-0242
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	0.24 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
ACTIVATED CHARCOAL (UNII: 2P3VWU3H10)
GLYCERIN (UNII: PDC6A3C0OX)
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)
HYDRATED SILICA (UNII: Y6O7T4G8P9)
SORBITOL (UNII: 506T60A25R)
WATER (UNII: 059QF0KO0R)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
SODIUM COCOYL GLYCINATE (UNII: XLU9KH03XM)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
XANTHAN GUM (UNII: TTV12P4NEE)
XYLITOL (UNII: VCQ006KQ1E)
GRAPEFRUIT SEED OIL (UNII: 598D944HOL)

Product Characteristics
Color		Score
Shape		Size
Flavor	COCONUT (Cocomint)	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 34362-0242-2	1 in 1 BOX	12/01/2018
1		141 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 final	part355	12/01/2018

Labeler - Caldwell Health LLC (828558713)

Establishment
Name	Address	ID/FEI	Business Operations
Lornamead Inc.		078584069	manufacture(34362-0242)